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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: Recruiting study of Bipolar Disorder and Migraine, sponsored by National Institute of Mental Health (NIMH).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Using standardized scales
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 |
What NCT05669703 shows while recruiting
NCT05669703 is an observational study that tracks outcomes without assigning an intervention. Its 1,260 participants enrollment target places it among the larger protocols in the corpus, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (288% higher).
The record links to 3 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT05669703 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05669703's enrollment target sits among peer trials
1,260 7th of 162 higher than 156 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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