Clinical trial Recruiting at 1 site Observational Ages 8 to 70

Understanding the link between exercise and mood in bipolar disorder

Official title: NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

Run by National Institutes of Health Clinical Center (CC) · NCT05669703 · Data updated 2026-11-12

This study is trying to see how exercise affects mood in people with bipolar disorder, major depression, and their healthy family members over two years.

Quick facts

Study typeObservational
Ages8 Years to 70 Years
SexAll
Enrollment1260 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedNovember 3, 2023
Main results expectedJuly 31, 2027
Study endsJuly 31, 2027
Registry record updatedOctober 7, 2026
Trial IDNCT05669703 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 12 to 60 with a history of mood disorders, as well as healthy relatives without such a history.

Probably not a fit

Patients with certain medical conditions that may interfere with exercise assessments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between physical activity, sleep, and mental health in individuals with and without mood disorders. Participants aged 12 to 60 will engage in a two-year study where they will complete electronic diaries and wear activity monitors to track their movement and mood. The study will include individuals with bipolar disorder, major depression, and healthy relatives, allowing researchers to assess the impact of motor activity on mood states. The goal is to replicate previous findings and further characterize the associations between these factors.

Why it matters

Potential benefit: If successful, this study could provide insights into how increasing physical activity may improve mood and overall mental health for individuals with mood disorders.

How similar studies have gone: Previous studies have shown a unidirectional association between motor activity and mood, suggesting that this approach has potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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).

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Kathleen R Merikangas, Ph.D. — National Institute of Mental Health (NIMH)
  • Study coordinator: Kathleen R Merikangas, Ph.D.
  • Email: familystudy@nih.gov
  • Phone: (301) 496-7773

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.