{"protocolSection":{"identificationModule":{"nctId":"NCT01787240","orgStudyIdInfo":{"id":"2012P001241"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Neurobiological Bases of Placebo Response in Major Depressive Disorder","officialTitle":"Neurobiological Bases of Placebo Response in Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2017-04","overallStatus":"TERMINATED","whyStopped":"Recruitment difficulties","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-08","type":"ACTUAL"},"completionDateStruct":{"date":"2016-08","type":"ACTUAL"},"studyFirstSubmitDate":"2013-01-16","studyFirstSubmitQcDate":"2013-02-06","studyFirstPostDateStruct":{"date":"2013-02-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-03-02","resultsFirstSubmitQcDate":"2017-03-02","resultsFirstPostDateStruct":{"date":"2017-04-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-04-18","lastUpdatePostDateStruct":{"date":"2017-05-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Cristina Cusin, MD","investigatorTitle":"Instructor HMS","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"We are doing this research study to find out if people who get better while taking a specific kind of antidepressant medication (a selective serotonin reuptake inhibitor, or SSRI) and people who get better while taking placebo (an inactive substance) have similar chemicals in their brains. Some participants may complete a procedure called Acute Tryptophan Depletion (ATD), which is a way to study the role of serotonin in depression. Some participants may also undergo a magnetic resonance-positron emission tomography (MR-PET) scan."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.","interventionNames":["Drug: Placebo"]},{"label":"Escitalopram 10mg","type":"EXPERIMENTAL","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.","interventionNames":["Drug: Escitalopram 10mg"]}],"interventions":[{"type":"DRUG","name":"Escitalopram 10mg","armGroupLabels":["Escitalopram 10mg"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Feasibility","description":"We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).","timeFrame":"This would occur at the first study visit (screening)."}],"secondaryOutcomes":[{"measure":"Effects of Acute Tryptophan Depletion on Mood","description":"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.\n\nThe HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.\n\nA negative change value refers to a decrease in HAM D score.","timeFrame":"Baseline, Visit 10 (after 9 weeks in study)"},{"measure":"Effects of Acute Tryptophan Depletion on Mood","description":"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.\n\nThe HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.\n\nA negative change value refers to a decrease in HAM D score.","timeFrame":"Baseline, Visit 5 (4 weeks into study)"}],"otherOutcomes":[{"measure":"Effects of Acute Tryptophan Depletion on Serotonin Binding","description":"We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.\n\nData were not collected","timeFrame":"Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Meets diagnostic criteria for Major Depressive Disorder\n* Written informed consent\n* Men or women aged 18-60 years old\n* A score of 18 or greater on the HAMD-28\n* Patient must continue to meet criteria for current MDD at baseline. Patients must have Clinical Global Impression Improvement (CGI) scores ≥ 3 (i.e. minimally improved or less) from the screen to the baseline visit\n* Agreeing to, and eligible for all procedures (only patients 18-45 will be eligible for MR-PET study)\n\nExclusion Criteria:\n\n* Pregnant women or women of child bearing potential not using a medically accepted means of contraception\n* Patients who are a serious suicide or homicide risk\n* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, uncontrolled seizure disorder\n* The following DSM-IV diagnoses: a) organic mental disorders b) substance use disorders, including alcohol, active within the last year; c) schizophrenia; d) delusional disorder; e) psychotic disorders not elsewhere classified; f) bipolar disorder; g) acute bereavement; h) borderline or antisocial personality disorder i) current primary diagnoses of panic disorder, social phobia, GAD, or OCD (disorders that present as chief complaint and/or have their onset preceding the onset of MDD), l) Patients with mood congruent or mood incongruent psychotic features\n* Currently taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressants, potential antidepressant augmenting agents (e.g., T3, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids). If it is determined that it is safe to discontinue a medication, the patient will be required to wait a period equivalent to at least 5 half lives of the drug before the screening\n* Patients who have taken an investigational psychotropic drug within the last year\n* Patients who have not responded to one or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g., for six weeks or more) over the past five years, as defined by the MGH-ATRQ\n* History of inadequate response or poor tolerability to citalopram or escitalopram\n* Any concomitant form of psychotherapy (depression-focused)\n* Receiving or have received during the index episode Vagal nerve stimulation, ECT or rTMS, or other somatic antidepressant treatments\n* Any reason not listed, determined by the site PI or study clinician, constituting good clinical practice and making participation in the study hazardous\n* Contraindications to fMRI scanning and MR-PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)\n* MR-PET-specific exclusion criteria: Patients who are younger than 18 or older than 45 years of age","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"60 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Cristina Cusin, M.D.","affiliation":"Massachusetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Massachusetts General Hospital Depression Clinical and Research Program","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nPlacebo"},{"id":"FG001","title":"Escitalopram 10mg","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nEscitalopram 10mg"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nPlacebo"},{"id":"BG001","title":"Escitalopram 10mg","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nEscitalopram 10mg"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"20"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"20"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.6","spread":"14.10"},{"groupId":"BG001","value":"33","spread":"11.64"},{"groupId":"BG002","value":"32.7","spread":"13.23"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"20"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Feasibility","description":"We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent of eligible patients","timeFrame":"This would occur at the first study visit (screening).","groups":[{"id":"OG000","title":"Eligible Patients","description":"Number of patients who were screened and were determined to be eligible for the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95.2"}]}]}]},{"type":"SECONDARY","title":"Effects of Acute Tryptophan Depletion on Mood","description":"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.\n\nThe HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.\n\nA negative change value refers to a decrease in HAM D score.","populationDescription":"Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Visit 10 (after 9 weeks in study)","groups":[{"id":"OG000","title":"Phase 2 Placebo","description":"Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2."},{"id":"OG001","title":"Phase 2 Active","description":"Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.0","spread":"6.4"},{"groupId":"OG001","value":"-13.0","spread":"12.1"}]}]}]},{"type":"SECONDARY","title":"Effects of Acute Tryptophan Depletion on Mood","description":"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.\n\nThe HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.\n\nA negative change value refers to a decrease in HAM D score.","populationDescription":"Patients who were randomized to take placebo or active drug","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Visit 5 (4 weeks into study)","groups":[{"id":"OG000","title":"Placebo","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nPlacebo"},{"id":"OG001","title":"Escitalopram 10mg","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nEscitalopram 10mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.4","spread":"8.5"},{"groupId":"OG001","value":"-8.8","spread":"6.3"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Effects of Acute Tryptophan Depletion on Serotonin Binding","description":"We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.\n\nData were not collected","populationDescription":"Data were not collected","reportingStatus":"POSTED","timeFrame":"Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)","groups":[{"id":"OG000","title":"Placebo","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nPlacebo"},{"id":"OG001","title":"Escitalopram 10mg","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nEscitalopram 10mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.","eventGroups":[{"id":"EG000","title":"Placebo","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nPlacebo","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":4,"seriousNumAtRisk":15,"otherNumAffected":12,"otherNumAtRisk":15},{"id":"EG001","title":"Escitalopram 10mg","description":"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.\n\nEscitalopram 10mg","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"otherNumAffected":1,"otherNumAtRisk":5}],"seriousEvents":[{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":5}]},{"term":"Chest pain","organSystem":"Cardiac 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infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":15},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":5}]},{"term":"Pancreatitis/Influenza","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":15},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":5}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":15},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":5}]},{"term":"Gas/irregular 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5}]},{"term":"Sexual Interest/Libido","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":1,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5}]},{"term":"Shoulder pain/numbness","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":5}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Cristina Cusin","organization":"MGH","email":"ccusin@partners.org","phone":"617 726 6421"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}