- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07810738
The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression. (BAARD)
Biotype-assigned Augmentation Approach in Resistant Late-Life Depression (BAARD): a Randomized Controlled Trial
The goal of this clinical trial is to test whether a personalized approach to treatment selection improves symptoms in older adults with treatment-resistant depression.
The main questions it aims to answer is:
Will using the BAARD predictive models to select medications lead to better depression outcomes, compared to randomly selecting medications?
Researchers will use the BAARD predictive models or random assignment to choose one of two medications to add to patients' current treatment. Patients will be asked to take either aripiprazole or bupropion along with their current medication.
Participants will:
Take Aripiprazole or Bupropion in addition to their current medication for 10 weeks.
Complete follow-up assessments every 1-2 weeks for checkups.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Ginger E Nicol, MD
- 전화번호: 314-747-1862
- 이메일: nicolg@wustl.edu
연구 연락처 백업
- 이름: Teddi L Gray
- 전화번호: 3147471862
- 이메일: grayt@wustl.edu
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 60 years and older
Diagnosis of treatment resistant depression, as verified by:
- Diagnosis of DSM-5 Major Depressive Disorder according to Structured Clinical Interview for DSM-5 Disorders (SCID) AND
- Baseline score of at least 10 on the 9-item Patient Health Questionnaire (PHQ-9) AND
- Either i. At least 2 prior antidepressant trials in the current episode of adequate dose and duration as determined with the Antidepressant Treatment History Form (ATHF), OR ii. one failed trial of a serotonin norepinephrine reuptake inhibitor (SNRI) of adequate dose and duration, including the current antidepressant, OR iii. failed at least 1 antidepressant trial of adequate dose and duration as determined with the ATHF in a prior episode and present in relapse while on another antidepressant of adequate dose and duration as determined with ATHF
- Ability to provide informed consent and complete the study assessments Taking antidepressant at adequate dose for at least 4 weeks
Exclusion Criteria:
- Dementia, as defined by Short Blessed Test score at least10 and/or documented diagnosis of dementia.
- Lifetime diagnosis of DSM 5 Bipolar I or II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, or current psychotic symptoms, or current (within 3 months) moderate to severe alcohol or substance use disorder as diagnosed by the SCID.
- High risk for suicide, defined as a 4 or 5 on C-SSRS46 (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases.
- Contraindication to study medications (aripiprazole or bupropion XL), as determined by study physician, including history of intolerance or non-response to bupropion (or equivalent bupropion containing drug) as an augmentation agent at greater than or equal to 300 mg or aripiprazole as an augmentation agent at greater than or equal to 5 mg.
- Physical conditions that, in the estimation of the study physician, prevent safe participation or suggest a high probability of death, or unstable medical illnesses that are not under medical management.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: BAARD-assigned
The BAARD predictive model will use individual participants' data to advise which of two treatments to select, aripiprazole or bupropion.
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Aripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg.
다른 이름들:
Bupropion augmentation will be started at 150 mg and increased based on symptoms and tolerability up to a maximum dose of 450 mg.
다른 이름들:
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활성 비교기: Randomly assigned
The randomly assigned arm will randomly assign one of two treatments to select, aripiprazole or bupropion.
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Aripiprazole augmentation will be started at 2 mg and increased based on symptoms and tolerability up to a maximum dose of 15 mg.
다른 이름들:
Bupropion augmentation will be started at 150 mg and increased based on symptoms and tolerability up to a maximum dose of 450 mg.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Remission from Depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS) score ≤10
기간: Week 10
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The MADRS is a 10-item instrument used to assess depression severity.
In this trial the MADRS will be used to assess remission of depression, defined as a MADRS score ≤10.
The total MADRS score ranges from 0-60, with higher scores indicating increased severity of depression.
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Week 10
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ginger E Nicol, Washington University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202603103
- 1UG3MH137353-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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