Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 12:23 AM
Study NCT ID:
NCT02017535
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgunlick@umn.edu', 'phone': '612-273-9844', 'title': 'Meredith Gunlicks-Stoessel', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '32 weeks', 'eventGroups': [{'id': 'EG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Children's Depression Rating Scale-Revised (CDRS-R)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'OG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}], 'classes': [{'title': '16 Weeks', 'categories': [{'measurements': [{'value': '32.38', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '7.23', 'groupId': 'OG001'}, {'value': '51', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '45', 'spread': 'NA', 'comment': 'Only one participant in this group, standard deviation can not be calculated.', 'groupId': 'OG003'}]}]}, {'title': '32 Weeks', 'categories': [{'measurements': [{'value': '29', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '5.51', 'groupId': 'OG001'}, {'value': '29', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '51', 'spread': 'NA', 'comment': 'Only one participant in this group, standard deviation can not be calculated.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks, 32 weeks', 'description': 'The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Global Assessment Scale (CGAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'OG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}], 'classes': [{'title': '16 weeks', 'categories': [{'measurements': [{'value': '65', 'spread': '4', 'groupId': 'OG000'}, {'value': '77', 'spread': '8', 'groupId': 'OG001'}, {'value': '53', 'spread': '4', 'groupId': 'OG002'}, {'value': '55', 'spread': 'NA', 'comment': 'Only one participant in this group, standard deviation can not be calculated.', 'groupId': 'OG003'}]}]}, {'title': '32 weeks', 'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'OG000'}, {'value': '71', 'spread': '10', 'groupId': 'OG001'}, {'value': '72', 'spread': '5', 'groupId': 'OG002'}, {'value': '49', 'spread': 'NA', 'comment': 'Only one participant in this group, standard deviation can not be calculated.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks, 32 weeks', 'description': 'The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'OG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}], 'classes': [{'title': '16 weeks', 'categories': [{'measurements': [{'value': '7.63', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '11.33', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '10', 'spread': '14.14', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only one participant in this group; data point is missing.', 'groupId': 'OG003'}]}]}, {'title': '32 weeks', 'categories': [{'measurements': [{'value': '5.86', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '9', 'spread': '10.82', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '41', 'spread': 'NA', 'comment': 'Only one participant in this group; data point is missing.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks, 32 weeks', 'description': 'BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Social Adjustment Scale - Self Report (SAS-SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'OG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'OG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}], 'classes': [{'title': '16 weeks', 'categories': [{'measurements': [{'value': '2.03', 'spread': '.49', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '.22', 'groupId': 'OG001'}, {'value': '2.75', 'spread': '.67', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Only one participant in this group; data point is missing.', 'groupId': 'OG003'}]}]}, {'title': '32 weeks', 'categories': [{'measurements': [{'value': '2.17', 'spread': '.55', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '.46', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '.17', 'groupId': 'OG002'}, {'value': '3.09', 'spread': 'NA', 'comment': 'Only one participant in this group; data point is missing.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks, 32 weeks', 'description': 'The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'FG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'FG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'FG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '6 IPT-A Sessions', 'description': 'IPT Only\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.'}, {'id': 'BG001', 'title': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'IPT with continued current fluoxetine dosage\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'BG002', 'title': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'IPT with new fluoxetine use\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'BG003', 'title': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'IPT with increased dose of fluoxetine\n\nInterpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.\n\nFluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.25', 'spread': '1.91', 'groupId': 'BG000'}, {'value': '15', 'spread': '1.73', 'groupId': 'BG001'}, {'value': '13', 'spread': '1.41', 'groupId': 'BG002'}, {'value': '16', 'spread': 'NA', 'comment': 'Single participant, SD cannot be calculated.', 'groupId': 'BG003'}, {'value': '14.93', 'spread': '1.82', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-06', 'size': 599323, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-15T15:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2013-12-16', 'resultsFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-09', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Depression Rating Scale-Revised (CDRS-R)", 'timeFrame': '16 weeks, 32 weeks', 'description': 'The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '16 weeks, 32 weeks', 'description': 'The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '16 weeks, 32 weeks', 'description': 'BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.'}, {'measure': 'Social Adjustment Scale - Self Report (SAS-SR)', 'timeFrame': '16 weeks, 32 weeks', 'description': 'The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adolescent Depression']}, 'referencesModule': {'references': [{'pmid': '30577943', 'type': 'DERIVED', 'citation': 'Gunlicks-Stoessel M, Mufson L, Bernstein G, Westervelt A, Reigstad K, Klimes-Dougan B, Cullen K, Murray A, Vock D. Critical Decision Points for Augmenting Interpersonal Psychotherapy for Depressed Adolescents: A Pilot Sequential Multiple Assignment Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):80-91. doi: 10.1016/j.jaac.2018.06.032. Epub 2018 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy.\n\nAim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.\n\nAim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.', 'detailedDescription': 'Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \\< 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents and parents must be English-speaking\n* Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \\< 3)).\n\nExclusion Criteria:\n\n\\- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \\< 3)) to acute phase treatment.'}, 'identificationModule': {'nctId': 'NCT02017535', 'acronym': 'PTAD GIA', 'briefTitle': 'An Adaptive Treatment Strategy for Adolescent Depression-Continuation', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Personalized Approach to Achieving a Sustained Response to Treatment for Adolescent Depression', 'orgStudyIdInfo': {'id': '1206M15365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '6 IPT-A Sessions', 'description': 'Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) only.\n\nDuring the Continuation IPT-A sessions, the therapist will continue to emphasize the interpersonal strategies that were learned and practiced during the acute phase, and address any current interpersonal problems before they result in a recurrence of depressive symptoms. Adolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions.', 'interventionNames': ['Behavioral: Interpersonal Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 IPT-A Sessions + Continue Current Dose of Fluoxetine', 'description': 'Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.\n\nAdolescents who have responded to acute phase treatment (CGI-I = much improved or very much improved) will attend 4 biweekly IPT-A sessions followed by 2 monthly sessions and will continue their acute phase fluoxetine dosing regimen and will meet with the psychiatrist on a monthly basis.', 'interventionNames': ['Drug: Fluoxetine', 'Behavioral: Interpersonal Psychotherapy']}, {'type': 'EXPERIMENTAL', 'label': '10 IPT-A Sessions + Begin Fluoxetine', 'description': 'Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.\n\nAdolescents who received only IPT-A during acute phase and who showed a partial response (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will begin treatment with fluoxetine during the continuation phase.The dosage schedule will be 10mg per day for the first week and 20mg per day for the following 5 weeks. If no treatment response is observed by the 6th week, the dosage can be increased to 40mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and biweekly thereafter. Pharmacotherapy sessions will include assessment of vital signs, adverse effects, safety, and symptomatic response.', 'interventionNames': ['Drug: Fluoxetine', 'Behavioral: Interpersonal Psychotherapy']}, {'type': 'EXPERIMENTAL', 'label': '10 IPT-A Sessions + Increase Dose of Fluoxetine', 'description': 'Participants in this group will receive interpersonal psychotherapy for adolescents (IPT-A) and fluoxetine treatment.\n\nAdolescents who received IPT-A and fluoxetine during the acute phase and were partial responders (CGI-I = minimally improved) will attend 8 weekly IPT-A sessions followed by 2 monthly sessions and will have their fluoxetine dose increased to 60mg. Partial responders will meet with the psychiatrist biweekly for the first 2 months and monthly for the second 2 months.', 'interventionNames': ['Drug: Fluoxetine', 'Behavioral: Interpersonal Psychotherapy']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': 'Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.', 'armGroupLabels': ['10 IPT-A Sessions + Begin Fluoxetine', '10 IPT-A Sessions + Increase Dose of Fluoxetine', '6 IPT-A Sessions + Continue Current Dose of Fluoxetine']}, {'name': 'Interpersonal Psychotherapy', 'type': 'BEHAVIORAL', 'otherNames': ['IPT'], 'description': 'Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.', 'armGroupLabels': ['10 IPT-A Sessions + Begin Fluoxetine', '10 IPT-A Sessions + Increase Dose of Fluoxetine', '6 IPT-A Sessions', '6 IPT-A Sessions + Continue Current Dose of Fluoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Department of Psychiatry', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Meredith Gunlicks-Stoessel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}