Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
2012년 10월 24일 업데이트: Prabha Sunderajan, University of Texas Southwestern Medical Center
Aripiprazole Augmentation of SSRI Antidepressant Therapy in Treatment Refractory Depression: Assessment of Symptom Reduction, Psychosocial Function, and Cognitive Function
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.
연구 개요
연구 유형
중재적
등록 (실제)
17
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Texas
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Dallas, Texas, 미국, 752390-9119
- University of Texas Southwestern Medical Center at Dallas
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age 18-65
- Primary diagnosis of Major Depressive Disorder (MDD)
- 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)
- 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
- 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
- Ability to read and write in English (required because instructions for cognitive testing and several questionnaires are available only in English)
Exclusion Criteria:
- Presence of untreated or unstable comorbid medical condition based on physician information or evidence at examination, such as hypertension, diabetes, hypothyroidism.
- Presence of known cardiovascular disease or seizure disorder.
- 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)
- Presence of organic brain injury or dementia, based on a cutoff score of < 20 on the Mini Mental Status Examination (MMSE).
- Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as described in Inclusion Criteria) including but not limited to anxiolytics, neuroleptics, mood stabilizers
- Hospitalization for mental illness within the past year.
- For women, currently pregnant or planning to become pregnant in the next year.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Aripiprazole augmentation
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
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varied dose (5, 10, 15 mg qd) for 6 wks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
기간: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
기간: baseline and 6 weeks
|
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.
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baseline and 6 weeks
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Spatial Working Memory (SWM) Between Errors for 6-move Problems
기간: baseline and 6 weeks
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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.
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baseline and 6 weeks
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Spatial Working Memory (SWM) Strategy Score
기간: baseline and 6 weeks
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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.
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baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Life Enjoyment and Satisfaction Questionnaire
기간: 6 weeks
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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.
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6 weeks
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Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
기간: 6 weeks
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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.
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6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2005년 10월 1일
기본 완료 (실제)
2009년 1월 1일
연구 완료 (실제)
2009년 1월 1일
연구 등록 날짜
최초 제출
2008년 1월 23일
QC 기준을 충족하는 최초 제출
2008년 2월 5일
처음 게시됨 (추정)
2008년 2월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 10월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 10월 24일
마지막으로 확인됨
2012년 3월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 042004-011
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