{"protocolSection":{"identificationModule":{"nctId":"NCT00149799","orgStudyIdInfo":{"id":"R01MH072854","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH072854"},"secondaryIdInfos":[{"id":"R01MH072854","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH072854"},{"id":"2004-P-002305","type":"OTHER","domain":"IRB Protocol Number"},{"id":"DSIR 83-ATSO"}],"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder","officialTitle":"Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder"},"statusModule":{"statusVerifiedDate":"2017-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-05"},"primaryCompletionDateStruct":{"date":"2013-03","type":"ACTUAL"},"completionDateStruct":{"date":"2013-03","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-06","studyFirstSubmitQcDate":"2005-09-06","studyFirstPostDateStruct":{"date":"2005-09-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-17","resultsFirstSubmitQcDate":"2014-11-14","resultsFirstPostDateStruct":{"date":"2014-11-21","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-11-30","lastUpdatePostDateStruct":{"date":"2017-12-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Sabine Wilhelm","investigatorTitle":"PhD","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"},{"name":"Rhode Island Hospital","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study's primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram.","detailedDescription":"We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (BDD). BDD, an often-delusional preoccupation with a nonexistent or slight defect in appearance, is a distressing, impairing, and common body image disorder. It is associated with high rates of functional impairment and markedly poor quality of life. It appears that serotonin reuptake inhibitors (SRIs) are often--and selectively--efficacious for BDD and that many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious SRI at some point, as the alternative is life-long treatment. However, no relapse prevention studies have been done. Such a study is important from a clinical and public health perspective, because BDD appears to often be chronic and require long-term treatment. It is therefore critically important to investigate the risk of relapse with SRI discontinuation, and whether continuation SRI treatment decreases relapse risk.\n\nSubjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. Our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will explore 1) Whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e.g., quality of life) than those on placebo; 2) Change in symptoms with continuation of escitalopram during the continuation phase; and 3) Acute treatment response.\n\nIn summary, this study will be the first relapse prevention study in BDD and the first study of continuation pharmacotherapy in BDD. It will provide critically important information on relapse with continuation versus discontinuation of an SRI, whether continuation treatment protects against relapse, and change in symptoms with continuation treatment. This study will yield unique and clinically important data, and will fill gaps in knowledge about this common, severe, and understudied illness."},"conditionsModule":{"conditions":["Anxiety Disorders","Somatoform Disorders"],"keywords":["Body Dysmorphic Disorder","Escitalopram","Lexapro","BDD","Body Image"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":100,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"In Phase I, all participants received open-label escitalopram for 14 weeks (at a dosage of 10 mg/d in weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter). Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to continue with escitalopram for Phase II of the study (Weeks 16-40)","interventionNames":["Drug: Escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants who responded to escitalopram in Phase I of the study (Weeks 1-14) were randomized to receive a placebo for Phase II of the study (Weeks 16-40)","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Placebo","description":"At the end of the initial 14-week phase (open-label escitalopram), participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)","description":"We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.","timeFrame":"Phase II: Biweekly for six months after randomization"}],"secondaryOutcomes":[{"measure":"Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)","description":"We calculated the proportion of patients who achieved response in Phase I, defined as a \\>=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.","timeFrame":"Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14"},{"measure":"Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)","description":"Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.","timeFrame":"Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40"},{"measure":"Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)","description":"Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.","timeFrame":"Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)"},{"measure":"Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)","description":"Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES\\_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.","timeFrame":"Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatient men and women age 18 and older\n* Diagnosis of BDD within 6 months of study start date based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)\n* Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale\n* Lives within driving distance of Boston, MA or Providence, RI\n\nExclusion Criteria:\n\n* Suicidal or homicidal tendencies\n* Alcohol/drug abuse or dependence within 3 months of study entry","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Sabine Wilhelm, PhD","affiliation":"Massachusetts General Hospital (MGH)","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Katharine Phillips, MD","affiliation":"Rhode Island Hospital (RIH)","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Rhode Island Hospital","city":"Providence","state":"Rhode Island","zip":"02906","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}}]},"referencesModule":{"references":[{"pmid":"31505519","type":"DERIVED","citation":"Fang A, Porth R, Phillips KA, Wilhelm S. Personality as a Predictor of Treatment Response to Escitalopram in Adults With Body Dysmorphic Disorder. J Psychiatr Pract. 2019 Sep;25(5):347-357. doi: 10.1097/PRA.0000000000000415."},{"pmid":"29557815","type":"DERIVED","citation":"Weingarden H, Shaw AM, Phillips KA, Wilhelm S. Shame and Defectiveness Beliefs in Treatment Seeking Patients With Body Dysmorphic Disorder. J Nerv Ment Dis. 2018 Jun;206(6):417-422. doi: 10.1097/NMD.0000000000000808."}],"seeAlsoLinks":[{"label":"Click here to go to the official website of the Body Dysmorphic Disorder Clinic at MGH","url":"http://www.mghocd.org/bdd"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 100 participants received open-label escitalopram in Phase I. Only those who completed Phase I, met criteria for response, and were willing to continue on in the study were subsequently randomized in Phase II (n=58).","groups":[{"id":"FG000","title":"Phase I: Open-Label Escitalopram","description":"Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter."},{"id":"FG001","title":"Phase II: Double-blind Escitalopram","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months."},{"id":"FG002","title":"Phase II: Double-blind Placebo","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months."}],"periods":[{"title":"Open Label Escitalopram (Phase I)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"14 completers were non-responders and 2 responders terminated the study after completing Phase I","numSubjects":"74"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Discontinuation (Phase II)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","comment":"Only responders who completed Phase I and were willing to continue were randomized in Phase II","numSubjects":"28"},{"groupId":"FG002","comment":"Only responders who completed Phase I and were willing to continue were randomized in Phase II","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"25"},{"groupId":"FG002","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"9"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"As the primary endpoint is based on participants randomized to Phase II (i.e. those who completed Phase I, met criteria for response, and were willing to continue on in the study), baseline characteristics are provided for the 58 Phase II participants.","groups":[{"id":"BG000","title":"Phase II: Escitalopram","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months."},{"id":"BG001","title":"Phase II: Placebo","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"58"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"37.3","spread":"12.4"},{"groupId":"BG001","value":"31.8","spread":"13.5"},{"groupId":"BG002","value":"33.5","spread":"12.4"}]}]}]},{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"55"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"18"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"51"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"48"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"58"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)","description":"We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.","populationDescription":"Intent-to-treat analysis of all 58 patients randomized to Phase II.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects who relapsed","timeFrame":"Phase II: Biweekly for six months after randomization","groups":[{"id":"OG000","title":"Phase II: Escitalopram","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months."},{"id":"OG001","title":"Phase II: Placebo","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"30"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"40"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.048","statisticalMethod":"Regression, Cox","statisticalComment":"p-value is based on the likelihood ratio Chi-Square statistic.","paramType":"Hazard Ratio (HR)","paramValue":"2.73","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.01","ciUpperLimit":"8.59"}]},{"type":"SECONDARY","title":"Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)","description":"We calculated the proportion of patients who achieved response in Phase I, defined as a \\>=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of subjects who responded","timeFrame":"Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14","groups":[{"id":"OG000","title":"Phase I: Open-Label Escitalopram","description":"Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67"}]}]}]},{"type":"SECONDARY","title":"Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)","description":"Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.","populationDescription":"A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40","groups":[{"id":"OG000","title":"Phase II: Escitalopram","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months."},{"id":"OG001","title":"Phase II: Placebo","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"29"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.5357143","spread":"4.4010280"},{"groupId":"OG001","value":"3.3793103","spread":"3.3744184"}]}]},{"title":"Week 16","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"30"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.8928571","spread":"4.1840906"},{"groupId":"OG001","value":"4.2333333","spread":"3.9799786"}]}]},{"title":"Week 18","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.2857143","spread":"5.5099717"},{"groupId":"OG001","value":"6.3703704","spread":"6.4875511"}]}]},{"title":"Week 20","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"28"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.8461538","spread":"5.5403416"},{"groupId":"OG001","value":"5.4285714","spread":"4.7798076"}]}]},{"title":"Week 22","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.2307692","spread":"3.5922995"},{"groupId":"OG001","value":"3.7407407","spread":"3.0457106"}]}]},{"title":"Week 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.625","spread":"3.3337862"},{"groupId":"OG001","value":"3.7727273","spread":"3.0539875"}]}]},{"title":"Week 26","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"25"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.8695652","spread":"4.0486176"},{"groupId":"OG001","value":"4.04","spread":"3.8457769"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.48","spread":"5.0259327"},{"groupId":"OG001","value":"4.4090909","spread":"3.4731499"}]}]},{"title":"Week 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.85","spread":"3.9373381"},{"groupId":"OG001","value":"4.5454545","spread":"4.0676104"}]}]},{"title":"Week 32","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.9565217","spread":"3.067102"},{"groupId":"OG001","value":"4.2","spread":"4.007887"}]}]},{"title":"Week 34","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"21"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.375","spread":"3.2412088"},{"groupId":"OG001","value":"4.7","spread":"4.5664682"}]}]},{"title":"Week 36","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.0416667","spread":"3.9943348"},{"groupId":"OG001","value":"5.4","spread":"5.2555735"}]}]},{"title":"Week 38","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.8181818","spread":"3.8623502"},{"groupId":"OG001","value":"3.4666667","spread":"3.8705235"}]}]},{"title":"Week 40","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"19"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.2400000","spread":"4.8500859"},{"groupId":"OG001","value":"4.1578947","spread":"5.0250833"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.\n\nNull hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \\[to be tested\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.0930","pValueComment":"A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Degrees of freedom=556","paramType":"Slope difference","paramValue":"-0.07006","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.04163"}]},{"type":"SECONDARY","title":"Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)","description":"Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.","populationDescription":"28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. 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Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage score","timeFrame":"Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)","groups":[{"id":"OG000","title":"Phase II: Escitalopram","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months."},{"id":"OG001","title":"Phase II: Placebo","description":"At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"30"}]}],"classes":[{"title":"Week 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"27"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"74.1785714","spread":"12.9930282"},{"groupId":"OG001","value":"70.9259259","spread":"16.0166402"}]}]},{"title":"Week 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"19"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"70.2727273","spread":"14.1528453"},{"groupId":"OG001","value":"67.3684211","spread":"16.0665648"}]}]},{"title":"Week 40","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"17"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"69.0833333","spread":"18.5376624"},{"groupId":"OG001","value":"68.6470588","spread":"15.2436100"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.\n\nNull hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \\[to be tested\\].","nonInferiorityType":"SUPERIORITY","pValue":"0.7724","pValueComment":"A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Degrees of freedom=36","paramType":"Slope difference","paramValue":"0.05723","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.1963"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization","eventGroups":[{"id":"EG000","title":"Phase I: Open-Label Escitalopram","description":"Participants taking 14 weeks of open-label escitalopram. 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