{"protocolSection":{"identificationModule":{"nctId":"NCT00608543","orgStudyIdInfo":{"id":"042004-011"},"organization":{"fullName":"University of Texas Southwestern Medical Center","class":"OTHER"},"briefTitle":"Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression","officialTitle":"Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function"},"statusModule":{"statusVerifiedDate":"2012-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-10"},"primaryCompletionDateStruct":{"date":"2009-01","type":"ACTUAL"},"completionDateStruct":{"date":"2009-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-01-23","studyFirstSubmitQcDate":"2008-02-05","studyFirstPostDateStruct":{"date":"2008-02-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-11-15","resultsFirstSubmitQcDate":"2012-10-24","resultsFirstPostDateStruct":{"date":"2012-10-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-10-24","lastUpdatePostDateStruct":{"date":"2012-10-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Prabha Sunderajan","investigatorTitle":"Assistant Professor","investigatorAffiliation":"University of Texas Southwestern Medical Center"},"leadSponsor":{"name":"University of Texas Southwestern Medical Center","class":"OTHER"},"collaborators":[{"name":"Bristol-Myers Squibb","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Our target population will have been adequately treated with one of three selective serotonin reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks and continue to experience symptoms of depression that have prompted them to seek additional treatment. Escitalopram, citalopram, and sertraline were selected for use in this study because they are among the most commonly selected SSRIs and they are associated with a reduced likelihood of drug-drug interactions with aripiprazole. After completion of the screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15 mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician, in conjunction with study participation. Symptom severity will be assessed on a weekly basis, and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We hypothesize that aripiprazole augmentation will be associated with reductions in symptom severity, and with improved performance on measures of psychosocial and cognitive function."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["cognitive function","psychosocial function","augmentation","treatment refractory depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":17,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Aripiprazole augmentation","type":"OTHER","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.","interventionNames":["Drug: Aripiprazole"]}],"interventions":[{"type":"DRUG","name":"Aripiprazole","description":"varied dose (5, 10, 15 mg qd) for 6 wks","armGroupLabels":["Aripiprazole augmentation"],"otherNames":["Abilify"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems","description":"The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.","timeFrame":"baseline and 6 weeks"},{"measure":"Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems","description":"The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.","timeFrame":"baseline and 6 weeks"},{"measure":"Spatial Working Memory (SWM) Between Errors for 6-move Problems","description":"The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.","timeFrame":"baseline and 6 weeks"},{"measure":"Spatial Working Memory (SWM) Strategy Score","description":"The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.","timeFrame":"baseline and 6 weeks"}],"secondaryOutcomes":[{"measure":"Quality of Life Enjoyment and Satisfaction Questionnaire","description":"The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.","timeFrame":"6 weeks"},{"measure":"Change in Hamilton Rating Scale for Depression (HRSD - 17-item)","description":"The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.","timeFrame":"6 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 18-65\n* Primary diagnosis of Major Depressive Disorder (MDD)\n* Completion of at least 8-12 weeks (and no longer than 6 months) of treatment with escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)\n* Hamilton Rating Scale for Depression, 17-item (HRSD17) score less than or equal to 14 and/or Clinical Global Impression - Severity (CGI-S) score less than or equal to 3\n* Self-reported difficulties with cognition and/or concentration, and an Inventory for Depressive Symptomatology Clinician-Rated, 30-item (IDS-C30) item #16 (Concentration and Decision Making) score less than or equal to 2\n* Ability to read and write in English (required because instructions for cognitive testing and several questionnaires are available only in English)\n\nExclusion Criteria:\n\n* Presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.\n* Presence of known cardiovascular disease or seizure disorder.\n* Presence of other primary psychiatric disorders or conditions (including depression due to medical conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or Not Otherwise Specified \\[NOS\\]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse or dependence within the last 6 months)\n* Presence of organic brain injury or dementia, based on a cutoff score of \\< 20 on the Mini Mental Status Examination (MMSE).\n* Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as described in Inclusion Criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers\n* Hospitalization for mental illness within the past year.\n* For women, currently pregnant or planning to become pregnant in the next year.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"University of Texas Southwestern Medical Center at Dallas","city":"Dallas","state":"Texas","zip":"752390-9119","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Open-label Aripiprazole Augmentation","description":"Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Open-label Aripiprazole Augmentation","description":"Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"17"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"17"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.18","spread":"7.95"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems","description":"The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.","populationDescription":"Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milliseconds","timeFrame":"baseline and 6 weeks","groups":[{"id":"OG000","title":"Open Label Aripiprazole Augmentation","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4485.50","spread":"6279.40"}]}]}]},{"type":"SECONDARY","title":"Quality of Life Enjoyment and Satisfaction Questionnaire","description":"The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.","populationDescription":"Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Open Label Aripiprazole Augmentation","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.81","spread":"0.48"}]}]}]},{"type":"SECONDARY","title":"Change in Hamilton Rating Scale for Depression (HRSD - 17-item)","description":"The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.","populationDescription":"Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Open Label Aripiprazole Augmentation","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.42","spread":"4.50"}]}]}]},{"type":"PRIMARY","title":"Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems","description":"The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.","populationDescription":"Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milliseconds","timeFrame":"baseline and 6 weeks","groups":[{"id":"OG000","title":"Open Label Aripiprazole Augmentation","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4676.10","spread":"8604.16"}]}]}]},{"type":"PRIMARY","title":"Spatial Working Memory (SWM) Between Errors for 6-move Problems","description":"The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.","populationDescription":"Completers because data were collected pre- and post-treatment","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of errors","timeFrame":"baseline and 6 weeks","groups":[{"id":"OG000","title":"Spatial Working Memory Between Errors for 6-move Problems","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.00","spread":"4.67"}]}]}]},{"type":"PRIMARY","title":"Spatial Working Memory (SWM) Strategy Score","description":"The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.","populationDescription":"Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline and 6 weeks","groups":[{"id":"OG000","title":"Open Label Aripiprazole Augmentation","description":"This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.15","spread":"4.52"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Open-label Aripiprazole Augmentation","description":"Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks","seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":14,"otherNumAtRisk":17}],"otherEvents":[{"term":"diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":17}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":17}]},{"term":"dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17}]},{"term":"nausea/vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17}]},{"term":"palpitations","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17}]},{"term":"dizziness on standing","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17}]},{"term":"chest pain","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17}]},{"term":"rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17}]},{"term":"increased perspiration","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17}]},{"term":"itching","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17}]},{"term":"dry skin","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17}]},{"term":"headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":17}]},{"term":"tremors","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17}]},{"term":"poor coordination","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17}]},{"term":"dizziness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17}]},{"term":"blurred vision","organSystem":"Eye disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17}]},{"term":"ringing in the ears","organSystem":"Ear and labyrinth disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17}]},{"term":"difficulty urinating","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17}]},{"term":"general malaise","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":17}]},{"term":"restlessness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":17}]},{"term":"fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":17}]},{"term":"decreased energy","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17}]},{"term":"painful urination","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17}]},{"term":"frequent urination","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":17}]},{"term":"menstrual irregularity","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17}]},{"term":"difficulty sleeping","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":17}]},{"term":"sleeping too much","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":17}]},{"term":"loss of sexual desire","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17}]},{"term":"trouble achieving orgasm","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":17}]},{"term":"trouble with erections","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17}]},{"term":"anxiety","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":17}]},{"term":"poor concentration","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Note that because this is an augmentation trial, reported AEs are due to combined treatment with escitalopram, citalopram, or sertraline AND aripiprazole."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr.Prabha Sunderajan","organization":"UT Southwestern Medical Center","email":"prabha.sunderajan@utsouthwestern.edu","phone":"214-648-0156"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D061218","term":"Depressive Disorder, Treatment-Resistant"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068180","term":"Aripiprazole"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D015363","term":"Quinolones"},{"id":"D011804","term":"Quinolines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"}]}},"hasResults":true}