Understanding the link between exercise and mood in bipolar disorder
NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
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 type | Observational |
|---|---|
| Enrollment | 1260 (estimated) |
| Ages | 8 Years to 70 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05669703 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with certain medical conditions that may interfere with exercise assessments may not benefit from this study.
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 performed: Previous studies have shown a unidirectional association between motor activity and mood, suggesting that this approach has potential for success.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.