{"protocolSection":{"identificationModule":{"nctId":"NCT03222570","orgStudyIdInfo":{"id":"PSYCH-2017-25767"},"secondaryIdInfos":[{"id":"R01MH113748","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH113748"}],"organization":{"fullName":"University of Minnesota","class":"OTHER"},"briefTitle":"An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression","officialTitle":"An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression"},"statusModule":{"statusVerifiedDate":"2025-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-02-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-04-28","type":"ACTUAL"},"completionDateStruct":{"date":"2024-04-28","type":"ACTUAL"},"studyFirstSubmitDate":"2017-07-13","studyFirstSubmitQcDate":"2017-07-17","studyFirstPostDateStruct":{"date":"2017-07-19","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-04-29","resultsFirstSubmitQcDate":"2025-06-12","resultsFirstPostDateStruct":{"date":"2025-07-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-06-12","lastUpdatePostDateStruct":{"date":"2025-07-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Minnesota","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36."},"conditionsModule":{"conditions":["Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":90,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"IPT-A Adaptive Treatment Strategy","type":"EXPERIMENTAL","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).","interventionNames":["Behavioral: Interpersonal Psychotherapy for Depressed Adolescents","Drug: Selective Serotonin Reuptake Inhibitor"]},{"label":"Usual Care","type":"ACTIVE_COMPARATOR","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.","interventionNames":["Other: Usual Care"]}],"interventions":[{"type":"BEHAVIORAL","name":"Interpersonal Psychotherapy for Depressed Adolescents","description":"IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.","armGroupLabels":["IPT-A Adaptive Treatment Strategy"]},{"type":"DRUG","name":"Selective Serotonin Reuptake Inhibitor","description":"Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline","armGroupLabels":["IPT-A Adaptive Treatment Strategy"]},{"type":"OTHER","name":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI","armGroupLabels":["Usual Care"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Children's Depression Rating Scale - Revised","description":"Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome","timeFrame":"16 weeks"}],"secondaryOutcomes":[{"measure":"Children's Global Assessment Scale","description":"Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome","timeFrame":"16 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC\n* Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised \\[CDRS-R\\])\n* Current impairment in psychosocial functioning (based on Children's Global Assessment Scale \\[CGAS\\])\n\nExclusion Criteria:\n\n* Non English-speaking\n* Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.\n* Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.\n* Currently taking medication for a psychiatric diagnosis other than ADHD","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","zip":"55414","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).","infoTypes":["STUDY_PROTOCOL"]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"IPT-A Adaptive Treatment Strategy","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).\n\nInterpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.\n\nSelective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline"},{"id":"FG001","title":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.\n\nUsual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"33"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"27"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"IPT-A Adaptive Treatment Strategy","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).\n\nInterpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.\n\nSelective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline"},{"id":"BG001","title":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.\n\nUsual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"90"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"90"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"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":"14.8","spread":"1.6"},{"groupId":"BG001","value":"14.2","spread":"2.0"},{"groupId":"BG002","value":"14.6","spread":"1.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"62"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"28"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"70"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}]}]}]},{"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":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"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":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"67"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"12"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"90"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Children's Depression Rating Scale - Revised","description":"Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"16 weeks","groups":[{"id":"OG000","title":"IPT-A Adaptive Treatment Strategy","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).\n\nInterpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.\n\nSelective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline"},{"id":"OG001","title":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.\n\nUsual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36.0","spread":"11.3"},{"groupId":"OG001","value":"37.5","spread":"11.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.76","statisticalMethod":"Regression, Linear","paramType":"Estimated mean difference","paramValue":"-0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.56","ciUpperLimit":"4.7","estimateComment":"Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure."}]},{"type":"SECONDARY","title":"Children's Global Assessment Scale","description":"Measure of general psychosocial functioning Minimum score: 1 Maximum score: 100 A higher score indicates a better outcome","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"16 weeks","groups":[{"id":"OG000","title":"IPT-A Adaptive Treatment Strategy","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).\n\nInterpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.\n\nSelective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline"},{"id":"OG001","title":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.\n\nUsual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"33"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.8","spread":"9.5"},{"groupId":"OG001","value":"63.3","spread":"12.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.32","statisticalMethod":"Regression, Linear","paramType":"Estimated mean difference","paramValue":"-2.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.42","ciUpperLimit":"2.3","estimateComment":"Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"16 weeks","eventGroups":[{"id":"EG000","title":"IPT-A Adaptive Treatment Strategy","description":"Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).\n\nInterpersonal Psychotherapy for Depressed Adolescents: IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.\n\nSelective Serotonin Reuptake Inhibitor: Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline","deathsNumAffected":0,"deathsNumAtRisk":57,"seriousNumAffected":0,"seriousNumAtRisk":57,"otherNumAffected":10,"otherNumAtRisk":57},{"id":"EG001","title":"Usual Care","description":"Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.\n\nUsual Care: Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":5,"otherNumAtRisk":33}],"otherEvents":[{"term":"Emergent or worsening suicidal ideation","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":57},{"groupId":"EG001","numAffected":5,"numAtRisk":33}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Meredith Gunlicks-Stoessel","organization":"University of Minnesota","email":"mgunlick@umn.edu","phone":"612-624-9249"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2023-09-05","uploadDate":"2025-04-23T21:55","filename":"Prot_SAP_000.pdf","size":938230}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2025-05-14","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003866","term":"Depressive Disorder"}],"ancestors":[{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000079062","term":"Interpersonal Psychotherapy"},{"id":"D017367","term":"Selective Serotonin Reuptake Inhibitors"}],"ancestors":[{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D014179","term":"Neurotransmitter Uptake Inhibitors"},{"id":"D049990","term":"Membrane Transport Modulators"},{"id":"D045504","term":"Molecular Mechanisms of Pharmacological Action"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"},{"id":"D018377","term":"Neurotransmitter Agents"},{"id":"D018490","term":"Serotonin Agents"},{"id":"D045505","term":"Physiological Effects of Drugs"}]}},"hasResults":true}