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Understanding Brain Reward Responses in Individuals With Major Depressive Disorder

2014年4月16日 更新者:Diego A. Pizzagalli、Mclean Hospital

Neuroimaging Studies of Reward Processing in Depression

This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD).

調査の概要

状態

完了

条件

詳細な説明

Major depressive disorder (MDD) is a severe form of depression that can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD may experience anhedonia, or the inability to gain pleasure from normally pleasurable experiences. Such individuals do not respond to motivational rewards in the same way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom of depression and it is not always remedied with antidepressant medication. Abnormal brain activity and processing may be the underlying cause of depression and specifically anhedonia. A better understanding of the brain mechanisms of depression may lead to the development of new effective medications or psychological treatments.

Event-related potential (ERP), which measures electrical activity in the brain, and functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes in brain activity, are two techniques that can identify abnormal areas of brain processing. The purpose of this study is to use ERP and fMRI to compare brain activity that is related to reward processing in individuals with MDD versus individuals without MDD.

This study will consist of 3 study visits; visits will be scheduled as close together as possible. At the first study visit, potential participants will be assessed with the SCID (Structured Clinical Interview for DSM-IV), which will identify individuals with the diagnostic criteria for MDD. A control group of non-depressed individuals will also be enrolled in the study. During the second and third study visits, participants will take part in a monetary reinforcement reward task followed by a signal detection reward task. Brain activity of all participants will be monitored during both tasks. During the second study visit, ERP will be used; during the third study visit, fMRI will be used. Demographic information will also be collected, and participants will complete several standardized questionnaires to assess mood. Some participants will be asked to return after eight weeks to complete the fMRI and EEG sessions again. Those who do complete all five sessions will be awarded a bonus.

研究の種類

観察的

入学 (実際)

87

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • The Depression Clinical and Research Program, Massachusetts General Hospital
      • Cambridge、Massachusetts、アメリカ、02138
        • Affective Neuroscience Laboratory, Department of Psychology, Harvard University
      • Charlestown、Massachusetts、アメリカ、02129
        • Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~64年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Control participants, Participants with MDD

説明

Overall Inclusion Criteria:

  • Right-handed
  • Agrees to use an effective form of contraception throughout the study

Inclusion Criteria for Depressed Participants:

  • Meets overall inclusion criteria
  • Meets DSM-IV diagnosis criteria for major depressive disorder
  • Score of at least 16 on the 21-item HAM-D scale

Overall Exclusion Criteria:

  • Left-handed or ambidextrous
  • Claustrophobic
  • Neurological or medical illness (e.g., attention deficit hyperactivity disorder, head injury, loss of consciousness, seizures)
  • Pregnant

Exclusion Criteria for Depressed Participants:

  • Meets any of the overall exclusion criteria
  • Has been treated with electroconvulsive therapy within 6 months of study entry
  • Has taken any benzodiazepine medications for at least 2 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
  • Has taken any dopaminergic medications (including methylphenidate) or neuroleptics for at least 6 months prior to study entry and discontinued use of the medication for reasons other than participating in the study
  • Has taken any fluoxetine medications for at least 6 weeks prior to study entry and discontinued use of the medication for reasons other than participating in the study
  • Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
  • Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry
  • Current or past history of MDD with psychotic features
  • Meets DSM-IV diagnosis criteria for organic mental disorder; substance use disorder (within 1 year of study entry); lifetime substance dependence; schizophrenia; delusional disorder; bipolar disorder; post-traumatic stress disorder; eating disorder; acute bereavement; severe borderline or antisocial personality disorder; or any psychotic disorder not otherwise specified
  • Current primary diagnosis of panic disorder, social phobia, generalized anxiety disorder, obsessive-compulsive disorder, or somatoform disorder

Exclusion Criteria for Control Participants

  • Meets any of the overall exclusion criteria
  • Diagnosed with any medical or neurological illness
  • Diagnosed with any current or past psychiatric illness, as assessed by the SCID-I, including substance abuse or dependence (e.g., alcohol)
  • Has taken any medications that may have antidepressant properties (including some herbal supplements) within 2 weeks of study entry
  • Has taken any psychotropic medications within 2 weeks of study entry
  • Has taken any medications that may affect blood flow (including some blood pressure medications) within 2 weeks of study entry

Exclusion Criteria for fMRI Studies:

  • Meets any of the overall exclusion criteria
  • Fails to meet safety standards for fMRI
  • Current back problems
  • Has strongly corrected vision, but does not wear contact lenses
  • Weighs more than 250 pounds or exceeds the limit of height-to-weight ratio for a comfortable fit in the scanner
  • Pregnant
  • Current alcohol or substance abuse
  • At risk for suicide or homicide

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
1
Control participants
2
Participants with MDD

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Performance on Monetary Incentive Delay task
時間枠:Given once during the second session for half an hour, and once during the third session for half an hour
This task features balanced incentive delivery and analytic strategies designed to identify activity specific to anticipation or consumption of incentives.
Given once during the second session for half an hour, and once during the third session for half an hour
Signal detection reward task
時間枠:Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes
This reward task provides an objective assessment of hedonic capacity. Due to the probabilistic nature of the task, participants cannot infer which stimulus is more advantageous based on the outcome of single trials but need to integrate reinforcement history over time to optimize behavior.
Given once during the second session for fifteen minutes, and once during the third session for fifteen minutes

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Diego A. Pizzagalli, PhD、Harvard University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年4月1日

一次修了 (実際)

2009年4月1日

研究の完了 (実際)

2009年4月1日

試験登録日

最初に提出

2005年9月14日

QC基準を満たした最初の提出物

2005年9月14日

最初の投稿 (見積もり)

2005年9月16日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年4月21日

QC基準を満たした最後の更新が送信されました

2014年4月16日

最終確認日

2014年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • R01MH068376 (米国 NIH グラント/契約)
  • DATR A3-NSS (Indiana University)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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