- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01916824
Effects of Treatment on Decision-making in Major Depression
연구 개요
상세 설명
During episodes of depression patients with major depressive disorder (MDD) may make sub-optimal decisions based on exaggerated negative beliefs about themselves, the future, or the world around them. These disruptions in decision-making contribute adversely to quality of life, in both work and personal realms. Although effective treatments for depression are available, very little work has explored the effects of treatment on how people make decisions. The specific aspects of decision-making that differ between depressed and health control individuals are unknown, and whether any changes in these decision-making features occur as a result of improvement from depression, or whether medication treatment itself can lead to changes in decision-making, even in the absence of clinical improvement.
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.
The overall goal of this study will be to identify whether decision-making characteristics in people with major depression is affected by treatment, and whether depressed patients make decisions differently from healthy controls. A total of 4 decision-making tasks and one control task will be administered via computer to eligible subjects. The specific tasks are:
- Risk Task - This task assesses tolerance of risk by having participants decide whether they wish to accept a specific dollar payout, or to play a lottery with an uncertain payout.
- Balloon Analogue Risk Task - The participant is presented with a balloon and offered the chance to earn money by pumping the balloon up by clicking a button. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes. Thus, each pump confers greater risk but also greater potential reward. If the participant chooses to cash-out prior to the balloon exploding then they collect the money earned for that trial, but if balloon explodes earnings for that trial are lost. Participants are not informed about the balloons breakpoints; the absence of this information allows for testing both participants' initial responses to the task and changes in responding as they gain experience with the task contingencies.
- Temporal Discounting Task - Participants are initially asked to choose between taking an immediate reward now or a larger reward at some time in the future. Decisions for seven time points over a 10-year time frame are proposed. The task is then repeated using choices between immediate and delayed losses, based on the same seven time points. This task assesses the manner in which subjects value immediate outcomes compared to long-term consequences.
- Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm commonly employed in behavioral economics to measure emotional reactions to unfair offers. In the UG, two subjects sequentially exchange real monetary amounts. Specifically, a proposer is provided with a sum of money by the experimenter ($10), and asked to share this amount of money with another player, the responder. The responder then decides whether to accept or reject the offer made by the proposer. If the responder accepts the offer, both players receive the respective amounts from the proposer's offer. If she rejects the offer made by the proposer, both players receive nothing ($0). This is best illustrated via the following two potential scenarios: 1. the proposer offers a fair split of $5 for himself and $5 for the responder. This is an offer that is typically accepted by a great majority of responders. 2. The proposer offers a split of $9 for himself and $1 for the responder. Such offers are commonly rejected by the majority of responders, despite incurring a financial loss of $1.
- Continuous Performance Task - This task involves identifying patterns of numbers briefly displayed on a computer screen. This task will serve as a control variable for attention in analyzing the results of the decision-making tasks.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory Mood and Anxiety Disorders Program
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for MDD Subjects:
- Male or female, age 18-65
- Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
- Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.
- Ability to visually read and understand English language
- Not currently taking an antidepressant.
- Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.
Inclusion Criteria for Healthy Control Subjects:
- Male or female, age 18-65
- No current DSM-IV TR diagnosis of a mental illness.
- No lifetime history of Major Depressive Disorder or Dysthymia.
- Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.
- Ability to visually read and understand English language
- Not currently taking any psychoactive medication
Exclusion Criteria for all subjects:
- Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
- Meet criteria for substance abuse or dependence within three months of the screening visit.
- Presents with a clinically significant suicide risk, as assessed by a study physician.
- Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
- Women who are currently pregnant or lactating, or plan to become pregnant during the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Participants with Major Depressive Disorder
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks.
Psychiatric follow-up will be performed during the study participation.
At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.
다른 이름들:
|
|
간섭 없음: Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Money Earned
기간: Baseline, Week 6
|
Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making. The specific tasks were:
|
Baseline, Week 6
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 행동 증상
- 정신 질환
- 기분 장애
- 우울증
- 우울 장애
- 우울 장애, 전공
- 약물의 생리적 효과
- 아드레날린 길항제
- 아드레날린 작용제
- 신경 전달 물질
- 약리작용의 분자기전
- 중추신경계 억제제
- 말초 신경계 작용제
- 효소 억제제
- 진통제
- 감각 시스템 에이전트
- 안정제
- 향정신성 약물
- 세로토닌 섭취 억제제
- 신경전달물질 섭취 억제제
- 막 수송 변조기
- 세로토닌 제제
- 도파민 작용제
- 세로토닌 5-HT2 수용체 길항제
- 세로토닌 길항제
- 항불안제
- 시토크롬 P-450 효소 억제제
- 항우울제, 2세대
- 세로토닌 및 노르아드레날린 재흡수 억제제
- 시토크롬 P-450 CYP2D6 억제제
- 세로토닌 5-HT3 수용체 길항제
- 도파민 흡수 억제제
- 히스타민 H1 길항제
- 히스타민 길항제
- 히스타민 작용제
- 아드레날린성 알파 길항제
- 아드레날린성 알파-2 수용체 길항제
- 설트랄린
- 둘록세틴 염산염
- 시탈로프람
- 파록세틴
- 부프로피온
- 데스벤라팍신 석시네이트
- 벤라팍신 염산염
- 미르타자핀
- 플루옥세틴
- 항우울제
기타 연구 ID 번호
- IRB00066705
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. .