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

NCT05669703 | Recruiting

• 2 other identifiers: 10000754000754-M
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Bipolar Disorder; Major Depression

Keywords

Mood Disorders; Actigraphy; CIRCADIAN RHYTHMS; Sleep; Ecological Momentary Assessments; Natural History

Outcome Measures

Primary Outcomes (3)

• Scores on standardized questionnaires

  Using standardized scales

  Every 6 months

• Subjective mood and energy ratings

  Using EMA

  4x daily

• Clinical rating scales

  Using standardized scales

  Every 6 months

Secondary Outcomes (3)

• Continuous heart rate measurements, blood pressure

  Before and after exercise

• Subjective mood and energy rating

  Before and after exercise

• Clinical rating scales

  Before and after exercise

Study Arms (1)

1

Community cohort of families

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Aged 8 and older
• Probands must have at least one first-degree relative agree to participate
• Affected probands must have a lifetime history of a mood disorder
• Unaffected probands must have no lifetime history of a mood disorder
• In good general health as evidenced by medical history
• Agreement to adhere to Lifestyle Considerations throughout study duration
• Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Migraine Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Depressive Disorder; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kathleen R Merikangas, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen R Merikangas, Ph.D.

CONTACT

(301) 496-7773; familystudy@nih.gov

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 3, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04-28

Locations

US (1)