- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02798094
Stress Sensitivity and Reward Responsivity in Depression (CAN-BIND-04)
Stress Sensitivity and Reward Responsivity: An Integration of Two Endophenotypes in Major Depression
연구 개요
상태
정황
상세 설명
Participants will participate in two 3-hour sessions separated by a week at Providence Care, Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the first session participants will complete a packet of questionnaires about their mood and take part in an interview about their mood, medications, drug use, and any other symptoms, as well as an interview about their relationships with their parents and any experiences of abuse. At the second session participants will participate in a stress test, which involves giving a speech to a panel. The investigators will also collect saliva samples to look at stress hormones. Participants will also complete a task on the computer that involves looking at cartoon faces and making decisions about them. At the third session, the investigators take images of of participant's brain using a magnetic resonance scanner.
Participants are invited to participate in a 6-month follow-up for this study, which would involve the same procedure as outline above.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Ontario
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Kingston, Ontario, 캐나다, K7L 3N6
- Queen's University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
For Depressed Participants:
Inclusion Criteria:
- Outpatients aged 18-65
- Currently suffering from unipolar depression
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
Exclusion Criteria:
- Clinical diagnosis of bipolar disorder, psychotic disorders, current alcohol/substance dependence, or significant medical comorbidity
- Treatment-resistant (defined as failing more than 3 trials of anti-depressant medication)
- History of neurological insult (e.g., concussion), neurological disease, seizure disorder
- Smokers
- Pregnant women
- Endocrine disorders
- High suicidal risk, defined by clinician judgement
For Healthy Control Participants:
Inclusion Criteria:
- Adults aged 18-65
- No history of Axis I disorders according to DSM-IV-TR criteria, as determined by the SCID
- No first-degree relatives diagnosed with bipolar disorder
- Fluency in English, sufficient to complete the interviews and self-report questionnaires
Exclusion Criteria:
- History of neurological insult (e.g., concussion), neurological disease, seizure disorder
- Smokers
- Pregnant women
- Endocrine disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Depressed Participants
No intervention
|
Healthy Control Participants
No intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Stress Sensitivity: Salivary Hormone and Stress Challenge Test (TSST)
기간: 2 hours after beginning of Time B Appointment
|
Participants are required to give a speech and an arithmetic test in front of a panel.
Saliva samples are collected at 8 points throughout the test.
|
2 hours after beginning of Time B Appointment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mood and Anxiety Symptom Questionnaire (MASQ)
기간: Administered at first baseline appointment and covers past 2 weeks
|
Self-report scale of general distress (GD), anhedonic depression (AD), and anxious arousal (AA) symptoms
|
Administered at first baseline appointment and covers past 2 weeks
|
Reward Responsivity: Probabilistic Reward Task
기간: Administered at second baseline appointment
|
Computerized task that requires participants to choose between two stimuli and develop a response bias to the more frequently rewarded stimulus.
|
Administered at second baseline appointment
|
Snaith Hamilton Pleasure Scale (SHAPS and SHAPS-C)
기간: Administered at first baseline appointment and covers past 2 weeks prior to interview
|
Self-report of anhedonia symptoms
|
Administered at first baseline appointment and covers past 2 weeks prior to interview
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kate Harkness, PhD, Queens University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .