Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00076258
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2004-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adding Exercise to Antidepressant Medication Treatment for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}, {'id': 'C065631', 'term': 'phosducin'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madhukar.trivedi@utsouthwestern.edu', 'phone': '214-648-0188', 'title': 'Madhukar H Trivedi', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'SSRI+ LD', 'description': 'A low dose aerobic exercise (LD) augmentation intervention to SSRI\n\nSSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.', 'otherNumAtRisk': 62, 'otherNumAffected': 62, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SSRI+ PHD', 'description': 'A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI\n\nSSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.', 'otherNumAtRisk': 64, 'otherNumAffected': 64, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea, constipation, dry mouth and Nausea', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 594, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 598, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitation, dizzy and chest pain', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 188, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 143, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash, perspiration, itching and dry skin', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 600, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 620, 'numAffected': 49}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache, tremors, coordination and dizzy', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 604, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 515, 'numAffected': 56}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision /ears ringing', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 207, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 288, 'numAffected': 25}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficult urination, painful urination,frequent urination and irregular menstruation', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 186, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 125, 'numAffected': 28}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty sleeping, sleeps too much', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 621, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 532, 'numAffected': 61}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'loss of desire, trouble orgasm and trouble erections', 'notes': 'Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 521, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 377, 'numAffected': 40}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SSRI+ LD', 'description': 'A low dose aerobic exercise (LD) augmentation intervention to SSRI\n\nSSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}, {'id': 'OG001', 'title': 'SSRI+ PHD', 'description': 'A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI\n\nSSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Remission rate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '29.5', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Both unadjusted and adjusted rates (for significant covariates) were reported'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Remission Rate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '28.3', 'groupDescription': 'For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \\< 0.06 and the NNT of 7.8 for the PHD versus the LD.', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).', 'unitOfMeasure': 'percentage of participants in remission', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SSRI+ LD', 'description': 'A low dose aerobic exercise (LD) augmentation intervention to SSRI\n\nSSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}, {'id': 'FG001', 'title': 'SSRI+ PHD', 'description': 'A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI\n\nSSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SSRI+ LD', 'description': 'A low dose aerobic exercise (LD) augmentation intervention to SSRI\n\nSSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}, {'id': 'BG001', 'title': 'SSRI+ PHD', 'description': 'A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI\n\nSSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '45.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '47.05', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hamilton Depression Rating Scale (17 item)', 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '17.8', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Hamilton Depression rating scale (17 item) is a clinical interview with scores that can range from 0-52. Higher scores indicate higher levels of depression symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2004-01-16', 'resultsFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2004-01-16', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-14', 'studyFirstPostDateStruct': {'date': '2004-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)', 'timeFrame': '12 weeks', 'description': 'The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Complementary Therapies'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '12392873', 'type': 'BACKGROUND', 'citation': 'Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. The DOSE study: a clinical trial to examine efficacy and dose response of exercise as treatment for depression. Control Clin Trials. 2002 Oct;23(5):584-603. doi: 10.1016/s0197-2456(02)00226-x.'}, {'pmid': '11427783', 'type': 'BACKGROUND', 'citation': "Dunn AL, Trivedi MH, O'Neal HA. Physical activity dose-response effects on outcomes of depression and anxiety. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S587-97; discussion 609-10. doi: 10.1097/00005768-200106001-00027."}, {'pmid': '10192589', 'type': 'BACKGROUND', 'citation': 'Crismon ML, Trivedi M, Pigott TA, Rush AJ, Hirschfeld RM, Kahn DA, DeBattista C, Nelson JC, Nierenberg AA, Sackeim HA, Thase ME. The Texas Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Major Depressive Disorder. J Clin Psychiatry. 1999 Mar;60(3):142-56.'}, {'pmid': '16394971', 'type': 'BACKGROUND', 'citation': 'Galper DI, Trivedi MH, Barlow CE, Dunn AL, Kampert JB. Inverse association between physical inactivity and mental health in men and women. Med Sci Sports Exerc. 2006 Jan;38(1):173-8. doi: 10.1249/01.mss.0000180883.32116.28.'}, {'pmid': '16883145', 'type': 'BACKGROUND', 'citation': 'Trivedi MH, Greer TL, Grannemann BD, Chambliss HO, Jordan AN. Exercise as an augmentation strategy for treatment of major depression. J Psychiatr Pract. 2006 Jul;12(4):205-13. doi: 10.1097/00131746-200607000-00002.'}, {'pmid': '27936452', 'type': 'DERIVED', 'citation': 'Toups M, Carmody T, Greer T, Rethorst C, Grannemann B, Trivedi MH. Exercise is an effective treatment for positive valence symptoms in major depression. J Affect Disord. 2017 Feb;209:188-194. doi: 10.1016/j.jad.2016.08.058. Epub 2016 Oct 15.'}, {'pmid': '27561137', 'type': 'DERIVED', 'citation': 'Suterwala AM, Rethorst CD, Carmody TJ, Greer TL, Grannemann BD, Jha M, Trivedi MH. Affect Following First Exercise Session as a Predictor of Treatment Response in Depression. J Clin Psychiatry. 2016 Aug;77(8):1036-42. doi: 10.4088/JCP.15m10104.'}, {'pmid': '23171815', 'type': 'DERIVED', 'citation': 'Rethorst CD, Sunderajan P, Greer TL, Grannemann BD, Nakonezny PA, Carmody TJ, Trivedi MH. Does exercise improve self-reported sleep quality in non-remitted major depressive disorder? Psychol Med. 2013 Apr;43(4):699-709. doi: 10.1017/S0033291712001675. Epub 2012 Aug 29.'}, {'pmid': '21658349', 'type': 'DERIVED', 'citation': 'Trivedi MH, Greer TL, Church TS, Carmody TJ, Grannemann BD, Galper DI, Dunn AL, Earnest CP, Sunderajan P, Henley SS, Blair SN. Exercise as an augmentation treatment for nonremitted major depressive disorder: a randomized, parallel dose comparison. J Clin Psychiatry. 2011 May;72(5):677-84. doi: 10.4088/JCP.10m06743.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).', 'detailedDescription': 'Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment.\n\nParticipants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Major Depressive Disorder\n* Score of 14 or higher on the Hamilton Depression Scale (HAM-D)\n* 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses\n* Sedentary lifestyle\n* Physically capable of exercise\n* Body mass index (BMI) less than 40 kg/m2\n* Willing and able to comply with study requirements\n\nExclusion Criteria:\n\n* Significant cardiovascular disease or other medical conditions\n* Uncontrolled hypertension\n* Abnormal exercise stress test\n* Hematologic disorders\n* Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)\n* Alcohol and/or substance abuse in the past 6 months\n* Hospitalization for mental illness within the past year\n* High suicide risk\n* Use of psychopharmacological or psychotherapeutic treatment other than SSRIs\n* Failure to respond to two or more adequate pharmacological treatments during the current depressive episode\n* Significantly elevated blood lipids\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00076258', 'acronym': 'TREAD', 'briefTitle': 'Adding Exercise to Antidepressant Medication Treatment for Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Treatment With Exercise Augmentation for Depression (TREAD)', 'orgStudyIdInfo': {'id': 'STU 092010-032'}, 'secondaryIdInfos': [{'id': 'R01MH067692-01', 'link': 'https://reporter.nih.gov/quickSearch/R01MH067692-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSRI+ LD', 'description': 'A low dose aerobic exercise (LD) augmentation intervention to SSRI', 'interventionNames': ['Behavioral: SSRI + LD']}, {'type': 'EXPERIMENTAL', 'label': 'SSRI+ PHD', 'description': 'A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI', 'interventionNames': ['Behavioral: SSRI + PHD']}], 'interventions': [{'name': 'SSRI + LD', 'type': 'BEHAVIORAL', 'description': 'Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.', 'armGroupLabels': ['SSRI+ LD']}, {'name': 'SSRI + PHD', 'type': 'BEHAVIORAL', 'description': 'Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.', 'armGroupLabels': ['SSRI+ PHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Madhukar Trivedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Madhukar H. Trivedi, MD', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}