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Search / Trial NCT05669703

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

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Dec 30, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mood Disorders Actigraphy Circadian Rhythms Sleep Ecological Momentary Assessments Natural History

ClinConnect Summary

The NIMH Rhythms and Blues Study is a research project aimed at understanding how physical activity, sleep, and mood are connected in people with mood disorders, like bipolar disorder and major depression, as well as in their healthy family members. The study is looking for participants aged 12 to 60 who have a mood disorder and their relatives who do not. Participants will take part in the study for up to two years, during which they’ll use a smartphone to answer questions about their feelings and daily activities, wear a device to track their movement, and record light exposure. Some participants will also take part in additional tests to monitor their heart rate, temperature, and sleep.

If you decide to join, you can expect to visit the NIH clinic twice for physical exams and tests, including riding a stationary bike and possibly having an imaging scan. You’ll also provide saliva samples and perform mental tasks on your smartphone. This study not only aims to gather valuable information about the links between exercise and mental health but also to help improve treatment and understanding of mood disorders. It’s a chance to contribute to important research while learning more about your own health.

Gender

ALL

Eligibility 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 12 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).

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Kathleen R Merikangas, Ph.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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