{"protocolSection":{"identificationModule":{"nctId":"NCT01473381","orgStudyIdInfo":{"id":"VLZ-MD-01"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Vilazodone in Major Depressive Disorder","officialTitle":"A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder","acronym":"VLZ-MD-01"},"statusModule":{"statusVerifiedDate":"2014-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-12"},"primaryCompletionDateStruct":{"date":"2013-06","type":"ACTUAL"},"completionDateStruct":{"date":"2013-06","type":"ACTUAL"},"studyFirstSubmitDate":"2011-11-14","studyFirstSubmitQcDate":"2011-11-16","studyFirstPostDateStruct":{"date":"2011-11-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-06-13","resultsFirstSubmitQcDate":"2014-08-06","resultsFirstPostDateStruct":{"date":"2014-08-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-08-06","lastUpdatePostDateStruct":{"date":"2014-08-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder","Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1162,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.","interventionNames":["Drug: Placebo to citalopram","Drug: Placebo to vilazodone"]},{"label":"Vilazodone 20 mg/day","type":"EXPERIMENTAL","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.","interventionNames":["Drug: Vilazodone","Drug: Placebo to citalopram","Drug: Placebo to vilazodone"]},{"label":"Vilazodone 40 mg/day","type":"EXPERIMENTAL","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.","interventionNames":["Drug: Vilazodone","Drug: Placebo to citalopram","Drug: Placebo to vilazodone"]},{"label":"Citalopram 40 mg/day","type":"ACTIVE_COMPARATOR","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.","interventionNames":["Drug: Placebo to vilazodone","Drug: Citalopram"]}],"interventions":[{"type":"DRUG","name":"Vilazodone","description":"Vilazodone was supplied as film-coated tablets.","armGroupLabels":["Vilazodone 20 mg/day","Vilazodone 40 mg/day"],"otherNames":["Viibryd"]},{"type":"DRUG","name":"Placebo to citalopram","description":"Placebo to citalopram was supplied as a capsule.","armGroupLabels":["Placebo","Vilazodone 20 mg/day","Vilazodone 40 mg/day"],"otherNames":["Celexa"]},{"type":"DRUG","name":"Placebo to vilazodone","description":"Placebo to vilazodone was supplied as film-coated tablets.","armGroupLabels":["Citalopram 40 mg/day","Placebo","Vilazodone 20 mg/day","Vilazodone 40 mg/day"]},{"type":"DRUG","name":"Citalopram","description":"Citalopram was supplied as encapsulated tablets.","armGroupLabels":["Citalopram 40 mg/day"],"otherNames":["Celexa"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10","description":"The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.","timeFrame":"Baseline to Week 10"}],"secondaryOutcomes":[{"measure":"Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score","description":"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: \"Considering your total clinical experience with this population, how mentally ill is the patient at this time?\" The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.","timeFrame":"Baseline to Week 10"},{"measure":"Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response","description":"The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.","timeFrame":"Baseline to Week 10"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men and women, 18-70 years of age.\n* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.\n* The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.\n\nExclusion Criteria:\n\n* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.\n* Patients with a history of meeting DSM-IV-TR criteria for:\n\n  * Any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode\n  * Any depressive episode with psychotic or catatonic features\n  * Panic disorder with or without agoraphobia\n  * Obsessive-compulsive disorder\n  * Schizophrenia, schizoaffective, or other psychotic disorder\n  * Bulimia or anorexia nervosa\n  * Presence of borderline personality disorder or antisocial personality disorder\n  * Mental retardation, dementia, amnesia, or other cognitive disorders.\n* Patients who are considered a suicide risk.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carl Gommoll, MS","affiliation":"Forest Laboratories","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Forest Investigative Site 036","city":"Birmingham","state":"Alabama","zip":"35216","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Forest Investigative Site 016","city":"Dothan","state":"Alabama","zip":"36303","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"Forest Investigative Site 033","city":"Scottsdale","state":"Arizona","zip":"85254","country":"United States","geoPoint":{"lat":33.50921,"lon":-111.89903}},{"facility":"Forest Investigative Site 027","city":"Fayetteville","state":"Arkansas","zip":"72703","country":"United States","geoPoint":{"lat":36.06258,"lon":-94.15743}},{"facility":"Forest Investigative Site 029","city":"Cerritos","state":"California","zip":"90703","country":"United States","geoPoint":{"lat":33.85835,"lon":-118.06479}},{"facility":"Forest Investigative Site 002","city":"Costa Mesa","state":"California","zip":"92626","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Forest Investigative Site 019","city":"Murrieta","state":"California","zip":"92562","country":"United States","geoPoint":{"lat":33.55391,"lon":-117.21392}},{"facility":"Forest Investigative Site 025","city":"Oceanside","state":"California","zip":"90703","country":"United States","geoPoint":{"lat":33.19587,"lon":-117.37948}},{"facility":"Forest Investigative Site 043","city":"Orange","state":"California","zip":"92868","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Forest Investigative Site 003","city":"Redlands","state":"California","zip":"92374","country":"United States","geoPoint":{"lat":34.05557,"lon":-117.18254}},{"facility":"Forest Investigative Site 046","city":"Sherman Oaks","state":"California","zip":"33026","country":"United States","geoPoint":{"lat":34.15112,"lon":-118.44925}},{"facility":"Forest Investigative Site 057","city":"Upland","state":"California","zip":"91786","country":"United States","geoPoint":{"lat":34.09751,"lon":-117.64839}},{"facility":"Forest Investigative Site 034","city":"Cromwell","state":"Connecticut","zip":"06416","country":"United States","geoPoint":{"lat":41.5951,"lon":-72.64537}},{"facility":"Forest Investigative Site 038","city":"Fort Myers","state":"Florida","zip":"33912","country":"United States","geoPoint":{"lat":26.62168,"lon":-81.84059}},{"facility":"Forest Investigative Site 018","city":"Gainsville","state":"Florida","zip":"32607","country":"United States"},{"facility":"Forest Investigative Site 055","city":"Hallandale","state":"Florida","zip":"33003","country":"United States","geoPoint":{"lat":25.9812,"lon":-80.14838}},{"facility":"Forest Investigative Site 063","city":"Jacksonville","state":"Florida","zip":"32256","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Forest Investigative Site 035","city":"Miami","state":"Florida","zip":"33134","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Forest Investigative Site 030","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site 062","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Forest Investigative Site 045","city":"Pembroke Pines","state":"Florida","zip":"33026","country":"United States","geoPoint":{"lat":26.00315,"lon":-80.22394}},{"facility":"Forest Investigative Site 051","city":"Tampa","state":"Florida","zip":"33613","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"Forest Investigative Site 032","city":"West Palm Beach","state":"Florida","zip":"33407","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"facility":"Forest Investigative Site 022","city":"Winter Park","state":"Florida","zip":"32789","country":"United States","geoPoint":{"lat":28.6,"lon":-81.33924}},{"facility":"Forest Investigative Site 060","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site 037","city":"Chicago","state":"Illinois","zip":"60634","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Forest Investigative Site 050","city":"Chicago","state":"Illinois","zip":"60640","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Forest Investigative Site 040","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"Forest Investigative Site 012","city":"Lafayette","state":"Indiana","zip":"47905","country":"United States","geoPoint":{"lat":40.4167,"lon":-86.87529}},{"facility":"Forest Investigative Site 053","city":"Prairie Village","state":"Kansas","zip":"66206","country":"United States","geoPoint":{"lat":38.99167,"lon":-94.63357}},{"facility":"Forest Investigative Site 020","city":"Baltimore","state":"Maryland","zip":"21208","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"Forest Investigative Site 031","city":"Boston","state":"Massachusetts","zip":"02135","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Forest Investigative Site 061","city":"Las Vegas","state":"Nevada","zip":"89102","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Forest Investigative Site 024","city":"Willingboro","state":"New Jersey","zip":"08046","country":"United States","geoPoint":{"lat":40.02789,"lon":-74.86905}},{"facility":"Forest Investigative Site 010","city":"Albuquerque","state":"New Mexico","zip":"87109","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"Forest Investigative Site 011","city":"Albuquerque","state":"New Mexico","zip":"87109","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"Forest Investigative Site 004","city":"Brooklyn","state":"New York","zip":"11214","country":"United States","geoPoint":{"lat":40.6501,"lon":-73.94958}},{"facility":"Forest Investigative Site 007","city":"Cedarhurst","state":"New York","zip":"11516","country":"United States","geoPoint":{"lat":40.62288,"lon":-73.7243}},{"facility":"Forest Investigative Site 058","city":"New York","state":"New York","zip":"10003","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Forest Investigative Site 047","city":"New York","state":"New York","zip":"10021","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Forest Investigative Site 039","city":"Cincinnati","state":"Ohio","zip":"45227","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Forest Investigative Site 042","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Forest Investigative Site 048","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Forest Investigative Site 066","city":"Portland","state":"Oregon","zip":"97210","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Forest Investigative Site 014","city":"Allentown","state":"Pennsylvania","zip":"18104","country":"United States","geoPoint":{"lat":40.60843,"lon":-75.49018}},{"facility":"Forest Investigative Site 049","city":"Bridgeville","state":"Pennsylvania","zip":"15017","country":"United States","geoPoint":{"lat":40.35618,"lon":-80.11006}},{"facility":"Forest Investigative Site 064","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Forest Investigative Site 013","city":"Austin","state":"Texas","zip":"78731","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Forest Investigative Site 021","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Forest Investigative Site 059","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Forest Investigative Site 065","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"Forest Investigative Site 054","city":"Spokane","state":"Washington","zip":"99204","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"facility":"Forest Investigative Site 052","city":"Middleton","state":"Wisconsin","zip":"53562","country":"United States","geoPoint":{"lat":43.09722,"lon":-89.50429}},{"facility":"Forest Investigative Site 056","city":"Milwaukee","state":"Wisconsin","zip":"53223","country":"United States","geoPoint":{"lat":43.0389,"lon":-87.90647}}]},"referencesModule":{"references":[{"pmid":"29608461","type":"DERIVED","citation":"Kornstein S, Chang CT, Gommoll CP, Edwards J. Vilazodone efficacy in subgroups of patients with major depressive disorder: a post-hoc analysis of four randomized, double-blind, placebo-controlled trials. Int Clin Psychopharmacol. 2018 Jul;33(4):217-223. doi: 10.1097/YIC.0000000000000217."},{"pmid":"26693034","type":"DERIVED","citation":"Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015."},{"pmid":"26039688","type":"DERIVED","citation":"Clayton AH, Gommoll C, Chen D, Nunez R, Mathews M. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial. Int Clin Psychopharmacol. 2015 Jul;30(4):216-23. doi: 10.1097/YIC.0000000000000075."},{"pmid":"25500685","type":"DERIVED","citation":"Mathews M, Gommoll C, Chen D, Nunez R, Khan A. Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Mar;30(2):67-74. doi: 10.1097/YIC.0000000000000057."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study."},{"id":"FG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11."},{"id":"FG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days."},{"id":"FG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"290"},{"groupId":"FG001","numSubjects":"292"},{"groupId":"FG002","numSubjects":"291"},{"groupId":"FG003","numSubjects":"289"}]},{"type":"Safety Population","achievements":[{"groupId":"FG000","numSubjects":"281"},{"groupId":"FG001","numSubjects":"288"},{"groupId":"FG002","numSubjects":"287"},{"groupId":"FG003","numSubjects":"282"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"210"},{"groupId":"FG001","numSubjects":"199"},{"groupId":"FG002","numSubjects":"189"},{"groupId":"FG003","numSubjects":"200"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"93"},{"groupId":"FG002","numSubjects":"102"},{"groupId":"FG003","numSubjects":"89"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"17"}]},{"type":"Insufficient Therapeutic Response","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"17"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"20"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"23"}]},{"type":"Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).","groups":[{"id":"BG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study."},{"id":"BG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11."},{"id":"BG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days."},{"id":"BG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"281"},{"groupId":"BG001","value":"288"},{"groupId":"BG002","value":"287"},{"groupId":"BG003","value":"282"},{"groupId":"BG004","value":"1138"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.0","spread":"13.0"},{"groupId":"BG001","value":"41.7","spread":"12.7"},{"groupId":"BG002","value":"40.8","spread":"13.2"},{"groupId":"BG003","value":"42.6","spread":"12.6"},{"groupId":"BG004","value":"41.8","spread":"12.8"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"< 20 years","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"18"}]}]},{"title":"≥ 20-29 years","categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"63"},{"groupId":"BG003","value":"53"},{"groupId":"BG004","value":"241"}]}]},{"title":"≥ 30-39 years","categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"68"},{"groupId":"BG003","value":"59"},{"groupId":"BG004","value":"234"}]}]},{"title":"≥ 40-49 years","categories":[{"measurements":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"76"},{"groupId":"BG004","value":"299"}]}]},{"title":"≥ 50-59 years","categories":[{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"244"}]}]},{"title":"≥ 60 years","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"26"},{"groupId":"BG004","value":"102"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"158"},{"groupId":"BG001","value":"166"},{"groupId":"BG002","value":"164"},{"groupId":"BG003","value":"165"},{"groupId":"BG004","value":"653"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"123"},{"groupId":"BG003","value":"117"},{"groupId":"BG004","value":"485"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"53"},{"groupId":"BG004","value":"210"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"222"},{"groupId":"BG001","value":"233"},{"groupId":"BG002","value":"244"},{"groupId":"BG003","value":"229"},{"groupId":"BG004","value":"928"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"197"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"202"},{"groupId":"BG003","value":"184"},{"groupId":"BG004","value":"788"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"83"},{"groupId":"BG004","value":"301"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"20"}]}]},{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"9"}]}]},{"title":"Native Hawaiian or Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"16"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"82.27","spread":"17.02"},{"groupId":"BG001","value":"82.55","spread":"18.16"},{"groupId":"BG002","value":"82.45","spread":"17.85"},{"groupId":"BG003","value":"82.37","spread":"18.30"},{"groupId":"BG004","value":"82.41","spread":"17.82"}]}]}]},{"title":"Weight","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"82.50","lowerLimit":"46.5","upperLimit":"127.1"},{"groupId":"BG001","value":"82.40","lowerLimit":"45.0","upperLimit":"137.9"},{"groupId":"BG002","value":"82.10","lowerLimit":"48.8","upperLimit":"132.9"},{"groupId":"BG003","value":"79.50","lowerLimit":"46.6","upperLimit":"151.6"},{"groupId":"BG004","value":"81.60","lowerLimit":"45.0","upperLimit":"151.6"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"169.03","spread":"9.38"},{"groupId":"BG001","value":"168.86","spread":"9.72"},{"groupId":"BG002","value":"169.87","spread":"9.71"},{"groupId":"BG003","value":"169.78","spread":"9.57"},{"groupId":"BG004","value":"169.39","spread":"9.60"}]}]}]},{"title":"Height","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"167.60","lowerLimit":"144.8","upperLimit":"198.1"},{"groupId":"BG001","value":"167.60","lowerLimit":"147.3","upperLimit":"195.6"},{"groupId":"BG002","value":"168.90","lowerLimit":"146.0","upperLimit":"193.0"},{"groupId":"BG003","value":"169.00","lowerLimit":"144.8","upperLimit":"200.7"},{"groupId":"BG004","value":"168.50","lowerLimit":"144.8","upperLimit":"200.7"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilograms per meter squared","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.70","spread":"5.40"},{"groupId":"BG001","value":"28.79","spread":"5.49"},{"groupId":"BG002","value":"28.45","spread":"5.43"},{"groupId":"BG003","value":"28.36","spread":"5.17"},{"groupId":"BG004","value":"28.58","spread":"5.37"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"kilograms per meter squared","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.30","lowerLimit":"18.5","upperLimit":"40.0"},{"groupId":"BG001","value":"28.20","lowerLimit":"18.4","upperLimit":"39.6"},{"groupId":"BG002","value":"27.80","lowerLimit":"18.3","upperLimit":"40.0"},{"groupId":"BG003","value":"27.90","lowerLimit":"18.0","upperLimit":"39.9"},{"groupId":"BG004","value":"28.10","lowerLimit":"18.0","upperLimit":"40.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10","description":"The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.","populationDescription":"Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 10","groups":[{"id":"OG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study."},{"id":"OG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11."},{"id":"OG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days."},{"id":"OG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"288"},{"groupId":"OG002","value":"284"},{"groupId":"OG003","value":"280"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.76","spread":"0.62"},{"groupId":"OG001","value":"-17.33","spread":"0.63"},{"groupId":"OG002","value":"-17.58","spread":"0.65"},{"groupId":"OG003","value":"-17.50","spread":"0.64"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0073","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-2.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.30","ciUpperLimit":"-0.84"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0034","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-2.82","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.57","ciUpperLimit":"-1.06"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0020","pValueComment":"P-value was provided for assay sensitivity. It was not adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-2.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.48","ciUpperLimit":"-1.00"}]},{"type":"SECONDARY","title":"Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score","description":"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: \"Considering your total clinical experience with this population, how mentally ill is the patient at this time?\" The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.","populationDescription":"Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 10","groups":[{"id":"OG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study."},{"id":"OG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11."},{"id":"OG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days."},{"id":"OG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"288"},{"groupId":"OG002","value":"284"},{"groupId":"OG003","value":"280"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.53","spread":"0.08"},{"groupId":"OG001","value":"-1.88","spread":"0.08"},{"groupId":"OG002","value":"-1.86","spread":"0.08"},{"groupId":"OG003","value":"-1.88","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0073","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.58","ciUpperLimit":"-0.13"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0097","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"-0.10"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0025","pValueComment":"P-value was provided for assay sensitivity. It was not adjusted for multiplicity.","statisticalMethod":"Mixed-effect model","paramType":"Mean Difference (Final Values)","paramValue":"-0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"-0.12"}]},{"type":"SECONDARY","title":"Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response","description":"The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.","populationDescription":"Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline to Week 10","groups":[{"id":"OG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study."},{"id":"OG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11."},{"id":"OG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days"},{"id":"OG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"288"},{"groupId":"OG002","value":"284"},{"groupId":"OG003","value":"280"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.3","lowerLimit":"21.2","upperLimit":"31.5"},{"groupId":"OG001","value":"29.9","lowerLimit":"24.6","upperLimit":"35.1"},{"groupId":"OG002","value":"33.5","lowerLimit":"28.0","upperLimit":"38.9"},{"groupId":"OG003","value":"31.1","lowerLimit":"25.7","upperLimit":"36.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3563","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Cochran-Mantel-Haenszel","statisticalComment":"The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.","paramType":"Mean Difference (Final Values)","paramValue":"3.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.9","ciUpperLimit":"10.9"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1611","pValueComment":"P-value was adjusted for multiplicity.","statisticalMethod":"Cochran-Mantel-Haenszel","statisticalComment":"The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.","paramType":"Mean Difference (Final Values)","paramValue":"7.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"14.6"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2672","pValueComment":"P-value was provided for assay sensitivity. It was not adjusted for multiplicity.","statisticalMethod":"Cochran-Mantel-Haenszel","statisticalComment":"The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.","paramType":"Mean Difference (Final Values)","paramValue":"4.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.7","ciUpperLimit":"12.2"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From the time that the participant signs the informed consent form until 30 days after the last dose of treatment.","description":"Safety population: All randomized participants who received at least 1 dose of double-blind investigational product (placebo, vilazodone, or citalopram).","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.","seriousNumAffected":3,"seriousNumAtRisk":281,"otherNumAffected":124,"otherNumAtRisk":281},{"id":"EG001","title":"Vilazodone 20 mg/Day","description":"Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.","seriousNumAffected":4,"seriousNumAtRisk":288,"otherNumAffected":168,"otherNumAtRisk":288},{"id":"EG002","title":"Vilazodone 40 mg/Day","description":"Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.","seriousNumAffected":4,"seriousNumAtRisk":287,"otherNumAffected":177,"otherNumAtRisk":287},{"id":"EG003","title":"Citalopram 40 mg/Day","description":"Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.","seriousNumAffected":6,"seriousNumAtRisk":282,"otherNumAffected":147,"otherNumAtRisk":282}],"seriousEvents":[{"term":"Abortion missed","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Accidental overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Asthma","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Bipolar I disorder","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Bronchitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Cardiomegaly","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Diverticulitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Electrocardiogram ST segment abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Gastric disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Haemorrhagic anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Hospitalisation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Ilium fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Migraine with aura","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Somnolence","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Status asthmaticus","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":1,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":1,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Traumatic renal injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Wrist fracture","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":1,"numAtRisk":282}]},{"term":"Abscess Neck","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Abscess Oral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]},{"term":"Obstructive Airways Disorder","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":281},{"groupId":"EG001","numAffected":0,"numAtRisk":288},{"groupId":"EG002","numAffected":0,"numAtRisk":287},{"groupId":"EG003","numAffected":0,"numAtRisk":282}]}],"otherEvents":[{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":281},{"groupId":"EG001","numAffected":75,"numAtRisk":288},{"groupId":"EG002","numAffected":76,"numAtRisk":287},{"groupId":"EG003","numAffected":30,"numAtRisk":282}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":281},{"groupId":"EG001","numAffected":62,"numAtRisk":288},{"groupId":"EG002","numAffected":69,"numAtRisk":287},{"groupId":"EG003","numAffected":55,"numAtRisk":282}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":281},{"groupId":"EG001","numAffected":42,"numAtRisk":288},{"groupId":"EG002","numAffected":41,"numAtRisk":287},{"groupId":"EG003","numAffected":42,"numAtRisk":282}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":281},{"groupId":"EG001","numAffected":22,"numAtRisk":288},{"groupId":"EG002","numAffected":19,"numAtRisk":287},{"groupId":"EG003","numAffected":18,"numAtRisk":282}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":281},{"groupId":"EG001","numAffected":11,"numAtRisk":288},{"groupId":"EG002","numAffected":19,"numAtRisk":287},{"groupId":"EG003","numAffected":5,"numAtRisk":282}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":281},{"groupId":"EG001","numAffected":18,"numAtRisk":288},{"groupId":"EG002","numAffected":18,"numAtRisk":287},{"groupId":"EG003","numAffected":19,"numAtRisk":282}]},{"term":"Somnolence","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":281},{"groupId":"EG001","numAffected":11,"numAtRisk":288},{"groupId":"EG002","numAffected":18,"numAtRisk":287},{"groupId":"EG003","numAffected":22,"numAtRisk":282}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":281},{"groupId":"EG001","numAffected":19,"numAtRisk":288},{"groupId":"EG002","numAffected":16,"numAtRisk":287},{"groupId":"EG003","numAffected":12,"numAtRisk":282}]},{"term":"Upper respiratory tract infection","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":281},{"groupId":"EG001","numAffected":14,"numAtRisk":288},{"groupId":"EG002","numAffected":15,"numAtRisk":287},{"groupId":"EG003","numAffected":14,"numAtRisk":282}]},{"term":"Nasopharyngitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":281},{"groupId":"EG001","numAffected":12,"numAtRisk":288},{"groupId":"EG002","numAffected":13,"numAtRisk":287},{"groupId":"EG003","numAffected":15,"numAtRisk":282}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":281},{"groupId":"EG001","numAffected":11,"numAtRisk":288},{"groupId":"EG002","numAffected":11,"numAtRisk":287},{"groupId":"EG003","numAffected":20,"numAtRisk":282}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc."},"pointOfContact":{"title":"Suresh Durgam, MD Clinical Asset Lead for Vilazodone - Senior Director - Clinical Development","organization":"Forest Research Institute","email":"suresh.durgam@frx.com","phone":"201 427-8000","phoneExt":"8172"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069503","term":"Vilazodone Hydrochloride"},{"id":"D015283","term":"Citalopram"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D007211","term":"Indoles"},{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"}]}},"hasResults":true}