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NIMH Rhythms and Blues Study: バイオリズムと反応性に関する前向き自然史研究

2026年10月6日 更新者:National Institute of Mental Health (NIMH)

Background:

Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.

Objective:

To better understand relationships among physical activity, sleep, and mental health.

Eligibility:

People aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.

Design:

Participants will be in the study up to 2 years.

For up to 20 days in a row, at 4 times during the study, participants will:

Complete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.

Wear an activity monitor, like a wristwatch, that records how much they move.

Wear a light sensor, as a necklace, to record the amount of light in their environment.

Some participants will do additional tests. Twice during the study, for 3 days in a row, they will:

Wear monitors to record their temperature, heart rate, and sleep.

Provide saliva samples.

Complete cognitive tasks on their smartphone.

Participants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.

Some participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.

調査の概要

状態

募集

詳細な説明

Study Description:

The overarching goal of this study is to investigate potential mechanisms underlying the association between motor activity and mood states and disorders. In a previous study using real-time tracking of objectively assessed motor activity and subjectively rated mood states with ecological momentary assessments (EMA), we found a unidirectional association between motor activity and mood that was especially notable among adults with bipolar I (BPI) disorder. The proposed study seeks to replicate these findings, and more extensively characterize the associations between motor activity and mood states by expanding the assessments of individual, physiologic, cognitive, and environmental correlates. This study will employ an intensive longitudinal design with combined ecological and laboratory assessments in the NIH Clinical Center in a sample of 280 probands with a lifetime history of bipolar I (BPI) disorder, bipolar II (BPII) disorder, major depressive disorder (MDD), or no lifetime history of a mood disorder. The study will also include up to 700 first-degree relatives (280 siblings and 420 offspring) and 280 spouses of the probands. A subset of the probands and relatives will participate in an outpatient and/or inpatient component. The overarching hypothesis is that increases in motor activity, especially exercise, are associated with improvements in mood states. These findings will have implications for interventions in both the general community and clinical samples of people with mood disorders.

Objectives: The study has four specific aims:

  1. Examine the associations between motor activity (using high resolution wearable sensors that are time-synchronized with EMA) and mood states in probands with a lifetime history of BPI disorder, BPII disorder, MDD, or no mood disorder (Multidomain Ecological Assessment).
  2. Evaluate associations between motor activity and mood states among first-degree relatives and spouses of probands with and without BPI disorder, BPII disorder, MDD, or other mood disorder (Familial Patterns).
  3. Quantify the impacts of exercise (a submaximal exercise test) on mood states and related domains by mood-disorder group in a controlled laboratory setting (Exercise).
  4. Explore potential correlates of the association between motor activity and mood states (Correlates).

Endpoints:

Primary Endpoints:

  1. Subjective mood and energy ratings assessed 4 times daily with EMA in ecological settings;
  2. Scores on standardized questionnaires of mood and mania/hypomania;
  3. Clinical rating scales;
  4. Within subject and group level averages and variability.

Secondary Endpoints:

  1. Subjective mood and energy ratings assessed with EMA before and after exercise;
  2. Clinical rating scales;
  3. Continuous heart rate measurements, blood pressure before and after (immediately, 0.5, 1,3, 12, and 24 hrs.) exercise.

Tertiary Endpoints:

Potential correlates of the association between motor activity and mood states including individual factors (e.g., age, sex, comorbidity, medical history), physiologic factors (e.g., heart rate, cortisol, light sensitivity), cognitive factors (e.g., performance on cognitive and neuroimaging tasks), and environmental factors (e.g., light, season, temperature).

研究の種類

観察的

入学 (推定)

1260

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。

研究連絡先

  • 名前:Kathleen R Merikangas, Ph.D.
  • 電話番号:(301) 496-7773
  • メール:familystudy@nih.gov

研究場所

    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • 募集
        • National Institutes of Health Clinical Center
        • コンタクト:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • 電話番号:TTY dial 711 800-411-1222
          • メール:ccopr@nih.gov

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

8年~70年 (子、大人、高齢者)

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

非確率サンプル

調査対象母集団

The sample will be recruited from several sources including: (1) our NIMH Family Study of Affective Spectrum Disorders; (2) ongoing clinical studies at NIH; and (3) volunteers from both clinical and community settings including the INOVA-Fairfax Health System, Medstar and the Johns Hopkins Health systems.

説明

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Aged 8 and older
  3. Probands must have at least one first-degree relative agree to participate
  4. Affected probands must have a lifetime history of a mood disorder
  5. Unaffected probands must have no lifetime history of a mood disorder
  6. In good general health as evidenced by medical history
  7. Agreement to adhere to Lifestyle Considerations throughout study duration
  8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

The presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:

  1. Pregnancy
  2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).

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

  • 観測モデル:FAMILY_BASED
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
1

Community cohort of families

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
Scores on standardized questionnaires
時間枠:Every 6 months

Using standardized scales

Every 6 months
Subjective mood and energy ratings
時間枠:4x daily

Using EMA

4x daily
Clinical rating scales
時間枠:Every 6 months

Using standardized scales

Every 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Continuous heart rate measurements, blood pressure
時間枠:Before and after exercise

Using standardized measures

Before and after exercise
Subjective mood and energy rating
時間枠:Before and after exercise

Using EMA

Before and after exercise
Clinical rating scales
時間枠:Before and after exercise

Using standardized scales

Before and after exercise

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。

捜査官

  • 主任研究者:Kathleen R Merikangas, Ph.D.、National Institute of Mental Health (NIMH)

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 (実際)

2023年11月3日

一次修了 (推定)

2027年7月31日

研究の完了 (推定)

2027年7月31日

試験登録日

最初に提出

2022年12月30日

QC基準を満たした最初の提出物

2022年12月30日

最初の投稿 (実際)

2023年1月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月7日

QC基準を満たした最後の更新が送信されました

2026年10月6日

最終確認日

2026年10月5日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Our intention is to share aggregated data.

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米国FDA規制機器製品の研究

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