NCT05669703 NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
| NCT ID | NCT05669703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Bipolar Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,260 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,260 participants in total. It began in 2023-11-03 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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).
Contact & Investigator
Kathleen R Merikangas, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT05669703 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 70 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05669703 currently recruiting?
Yes, NCT05669703 is actively recruiting participants. Contact the research team at familystudy@nih.gov for enrollment information.
Where is the NCT05669703 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05669703 clinical trial?
NCT05669703 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Kathleen R Merikangas, Ph.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 1,260 participants.
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