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NCT05669703 · ClinicalTrials.gov registry record
NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
A clinical trial of Bipolar Disorder and Migraine, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- 1,260
- Enrollment target
- 1
- Study location
NCT05669703 is a study of Bipolar Disorder and Migraine that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 1,260 participants, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (288% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05669703, a study of Bipolar Disorder and Migraine, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- 1,260 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,260 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2026-07-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05669703
The ClinicalTrials.gov registry entry for NCT05669703 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (288% higher). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT05669703 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05669703 about?
NCT05669703 is a clinical study titled "NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder". 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 m...
What is the current status of trial NCT05669703?
This trial is currently recruiting. The enrollment target is 1,260 participants. The study started on 2023-11-03. Estimated completion is 2026-07-31.
What conditions does trial NCT05669703 study?
This clinical trial studies the following conditions: Bipolar Disorder, Migraine, Major Depression.
Who is sponsoring clinical trial NCT05669703?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05669703 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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