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Brain Mechanisms of Emotion and Motivation: A Mind-Body Study (MIDAS)

2018년 5월 18일 업데이트: Diego A. Pizzagalli, Mclean Hospital
The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews.

연구 개요

상태

완전한

상세 설명

The purpose of this research study is to investigate how the brain processes emotions, and the way these processes affect behavior. Specifically, we hypothesize that individual differences in reward responsiveness will correlate with differential activation in mesolimbic regions of the brain and predict future wellbeing in follow-up interviews. Participating in this study involves up to two sessions and up to 7.5 hours. In the present observational study, each participant will be exposed to the same experimental procedure.

Visit 1 will take about 4.5 hours, from 12pm to 4:30pm. The visit will take place at the Center for Depression, Anxiety and Stress at McLean. During this visit, a clinical interviewer will conduct a diagnostic SCID interview to ensure that participants qualify to take part in this research study. Participants will then complete several tasks. These tasks include several different "game-like" situations and arithmetic riddles, all of which are simple but require participants to work hard and remain alert for an extended period of time. The goal during these games is to earn as much money as you can or to avoid losing money. Participants will do so by responding (pressing a keyboard button) quickly and accurately. These tasks are intended as assessment tools, and are not a form of therapy or intervention. In addition, we will test participants' ability to keep their hand in cold water. Participants will also be asked to provide blood (via a saline IV) and saliva samples at different times during this session, and we will also conduct urine drug and pregnancy tests. The IV will be in place for a total of around 3 hours, and is used to reduce discomfort from multiple blood draws.

Visit 2 will take place at the McLean Imaging Center at McLean Hospital. During the first part of the session, the fMRI scanner will take structural pictures of brain anatomy. Next, additional images will be obtained while participants complete several different "game-like" tasks, similar to the tasks performed in visit 1. Again, these tasks are intended as assessment tools, and are not a form of therapy or intervention. The whole fMRI session will last up to about 2.5 hours; participants will spend about 1.5 hours in the fMRI machine, and about a half-an-hour completing questionnaires and providing saliva samples. Prior to the fMRI scan, another urine sample will be obtained to check for drugs which may interfere with the experiment.

After the second study session is complete, participants will be re-contacted through the internet every four weeks for a total of six months, to complete some questionnaires. At the end of six months, participants will be asked to return to McLean to complete an in-person interview. This follow-up period is purely observational and not intended to assess health outcomes, as there is no intervention in this study.

연구 유형

관찰

등록 (실제)

88

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Belmont, Massachusetts, 미국, 02478
        • Mclean Hospital

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)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Community sample

설명

Inclusion Criteria:

  • Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP)
  • Written informed consent
  • Both genders and all ethnic origins, age between 18 and 45
  • Right-handed
  • Absence of any medications for at least 3 weeks
  • Absence of pregnancy as determined by completion of a negative urine pregnancy test prior to the MRI scan
  • Fluent English speaker
  • Absence of current drug use (cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates) as assessed by a urine drug test.

Exclusion Criteria:

  • Pregnant or currently breast-feeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
  • History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
  • History of seizure disorder
  • Failure to meet standard fMRI safety requirements
  • History of head injury
  • History or current diagnosis of any DSM-IV psychiatric illnesses; Presence of a DSM-IV psychiatric illness within a first-degree relative
  • History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
  • History of use of dopaminergic drugs (including methylphenidate)
  • History or current diagnosis of dementia
  • Patients with mood congruent or mood incongruent psychotic features
  • History or current use of any psychiatric medication
  • Current use of any drug or herbal supplement with well-characterized psychotropic effects (e.g. St. John's wort)
  • Clinical or laboratory evidence of hypothyroidism
  • Diabetes with poor glucose control
  • Currently taking medication that affects blood flow, e.g. certain blood pressure medications
  • Evidence of significant inconsistencies in self-report.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Healthy controls
Individuals with no psychiatric diagnosis as determined by structured clinical interview for DSM-IV (SCID) at time of enrollment. There is no intervention administered in this study.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Brain Activity during Instrumental Learning Task
기간: 2 hour long scan during session 2
Functional magnetic resonance imaging (fMRI) data are acquired while participants perform the instrumental learning task. fMRI data allows us to measure aspects of brain activity.
2 hour long scan during session 2
Change in Behavioral Performance in Instrumental Learning Task
기간: Administered during session 1 twice for a total of 10 minutes
The instrumental learning task is designed to measure participant learning from reward and punishment. It will be administered twice during session 1 to calculate changes in reward and punishment sensitivity.
Administered during session 1 twice for a total of 10 minutes
Behavioral performance in Effort-Expenditure for Rewards Task
기간: 15 minute task during session 2
The instrumental learning task is designed to measure reward sensitivity.
15 minute task during session 2
Change in Questionnaire Data
기간: Administered continuously during the two study sessions (total 7 hours); follow-up questionnaires sent out every 2 weeks for a total of 4 months
At all sessions participants will fill out self-report questionnaires regarding aspects of mood and affect, demographics, caffeine and alcohol consumption, etc. Questionnaires will be completed on paper forms or through the electronic data entry system "RedCap Survey", a HIPPAA compliant secure and encrypted online database. We will use these data to assess changes in participant behavior.
Administered continuously during the two study sessions (total 7 hours); follow-up questionnaires sent out every 2 weeks for a total of 4 months
Change in Behavioral Performance in Probabilistic Reward Task
기간: Given three times during session 1 for a total of 35 minutes
The probabilistic reward task is designed to measure sensitivity to reward and reward learning. It will be administered three times during session 1 to calculate changes in reward and punishment sensitivity.
Given three times during session 1 for a total of 35 minutes
Life Events and Difficulties (LEDS) interview
기간: 6 months after completion of session 2
The LEDS interview is designed to assess life experiences and emotional responses.
6 months after completion of session 2
Change in salivary hormone levels
기간: During sessions 1 and 2 (a total of 7 hours) saliva samples will be repeatedly gathered
A total of ten saliva samples will be taken before, during and after the tasks in sessions 1 and 2 to monitor changes in hormone levels.
During sessions 1 and 2 (a total of 7 hours) saliva samples will be repeatedly gathered
Salivary genetic analysis
기간: 5 minute saliva sample gathered at the beginning of session 1
One Saliva sample will be gathered from each participant to analyze genetic markers.
5 minute saliva sample gathered at the beginning of session 1
Change in inflammatory cytokine levels in blood plasma
기간: 3 blood samples, each taking 10 minutes, gathered over the course of session 1 for a total of 30 minutes
Blood will be drawn from participants before, during and after the various tasks in session 1. Changes in inflammatory cytokine levels in blood plasma will be measured to gauge physiological responses to tasks.
3 blood samples, each taking 10 minutes, gathered over the course of session 1 for a total of 30 minutes
Behavioral Performance in Instrumental Learning Task
기간: Administered in session 2 during two hour long scan
The instrumental learning task is designed to measure participant learning from reward and punishment.
Administered in session 2 during two hour long scan

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Behavioral performance in Reaction Time task
기간: Given 3 times during session 1 for a total of 9 minutes
The Reaction Time task is designed to control for individual differences in reaction time and fatigue during the session.
Given 3 times during session 1 for a total of 9 minutes

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

2013년 3월 1일

기본 완료 (실제)

2016년 1월 1일

연구 완료 (실제)

2016년 1월 1일

연구 등록 날짜

최초 제출

2013년 5월 2일

QC 기준을 충족하는 최초 제출

2013년 5월 8일

처음 게시됨 (추정)

2013년 5월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 5월 18일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2012P001786
  • 5R01MH068376 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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