Bipolar DisorderNCT05669703
NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
An observational study of Bipolar Disorder and Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Major Depression, Migraine
- How many people
- 1,260 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Study Description:
The overarching goal of this study is to investigate potential mechanisms underlying the association between motor activity and mood states and disorders. In a previous study using real-time tracking of objectively assessed motor activity and subjectively rated mood states with ecological momentary assessments (EMA), we found a unidirectional association between motor activity and mood that was especially notable among adults with bipolar I (BPI) disorder. The proposed study seeks to replicate these findings, and more extensively characterize the associations between motor activity and mood states by expanding the assessments of individual, physiologic, cognitive, and environmental correlates. This study will employ an intensive longitudinal design with combined ecological and laboratory assessments in the NIH Clinical Center in a sample of 280 probands with a lifetime history of bipolar I (BPI) disorder, bipolar II (BPII) disorder, major depressive disorder (MDD), or no lifetime history of a mood disorder. The study will also include up to 700 first-degree relatives (280 siblings and 420 offspring) and 280 spouses of the probands. A subset of the probands and relatives will participate in an outpatient and/or inpatient component. The overarching hypothesis is that increases in motor activity, especially exercise, are associated with improvements in mood states. These findings will have implications for interventions in both the general community and clinical samples of people with mood disorders.
Objectives: The study has four specific aims:
- Examine the associations between motor activity (using high resolution wearable sensors that are time-synchronized with EMA) and mood states in probands with a lifetime history of BPI disorder, BPII disorder, MDD, or no mood disorder (Multidomain Ecological Assessment).
- Evaluate associations between motor activity and mood states among first-degree relatives and spouses of probands with and without BPI disorder, BPII disorder, MDD, or other mood disorder (Familial Patterns).
- Quantify the impacts of exercise (a submaximal exercise test) on mood states and related domains by mood-disorder group in a controlled laboratory setting (Exercise).
- Explore potential correlates of the association between motor activity and mood states (Correlates).
Endpoints:
Primary Endpoints:
- Subjective mood and energy ratings assessed 4 times daily with EMA in ecological settings;
- Scores on standardized questionnaires of mood and mania/hypomania;
- Clinical rating scales;
- Within subject and group level averages and variability.
Secondary Endpoints:
- Subjective mood and energy ratings assessed with EMA before and after exercise;
- Clinical rating scales;
- Continuous heart rate measurements, blood pressure before and after (immediately, 0.5, 1,3, 12, and 24 hrs.) exercise.
Tertiary Endpoints:
Potential correlates of the association between motor activity and mood states including individual factors (e.g., age, sex, comorbidity, medical history), physiologic factors (e.g., heart rate, cortisol, light sensitivity), cognitive factors (e.g., performance on cognitive and neuroimaging tasks), and environmental factors (e.g., light, season, temperature).
- Conditions
- Bipolar Disorder, Major Depression, Migraine
- Keywords
- Mood Disorders, Actigraphy, CIRCADIAN RHYTHMS, Sleep, Ecological Momentary Assessments, Natural History
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Migraine Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Community cohort of families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on standardized questionnaires
Using standardized scales
Measured: Every 6 months
Subjective mood and energy ratings
Using EMA
Measured: 4x daily
Clinical rating scales
Using standardized scales
Measured: Every 6 months
Secondary outcomes (3)
Continuous heart rate measurements, blood pressure
Using standardized measures
Measured: Before and after exercise
Subjective mood and energy rating
Using EMA
Measured: Before and after exercise
Clinical rating scales
Using standardized scales
Measured: Before and after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start3 Nov 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen R Merikangas, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669703
- Sponsor's protocol ID
- 10000754
- Other IDs
- 000754-M
- Status last verified
- 5 Oct 2026
- First submitted
- 30 Dec 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our intention is to share aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05669703
- Acronym / sponsor ID
- 10000754
- Conditions
- Bipolar Disorder, Major Depression, Migraine
- Keywords
- Mood Disorders, Actigraphy, CIRCADIAN RHYTHMS, Sleep, Ecological Momentary Assessments, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
The overarching goal of this study is to investigate potential mechanisms underlying the association between motor activity and mood states and disorders. In a previous study using real-time tracking of objectively assessed motor activity and subjectively rated mood states with ecological momentary assessments (EMA), we found a unidirectional association between motor activity and mood that was especially notable among adults with bipolar I (BPI) disorder. The proposed study seeks to replicate these findings, and more extensively characterize the associations between motor activity and mood states by expanding the assessments of individual, physiologic, cognitive, and environmental correlates. This study will employ an intensive longitudinal design with combined ecological and laboratory assessments in the NIH Clinical Center in a sample of 280 probands with a lifetime history of bipolar I (BPI) disorder, bipolar II (BPII) disorder, major depressive disorder (MDD), or no lifetime history of a mood disorder. The study will also include up to 700 first-degree relatives (280 siblings and 420 offspring) and 280 spouses of the probands. A subset of the probands and relatives will participate in an outpatient and/or inpatient component. The overarching hypothesis is that increases in motor activity, especially exercise, are associated with improvements in mood states. These findings will have implications for interventions in both the general community and clinical samples of people with mood disorders.
Objectives: The study has four specific aims:
- Examine the associations between motor activity (using high resolution wearable sensors that are time-synchronized with EMA) and mood states in probands with a lifetime history of BPI disorder, BPII disorder, MDD, or no mood disorder (Multidomain Ecological Assessment).
- Evaluate associations between motor activity and mood states among first-degree relatives and spouses of probands with and without BPI disorder, BPII disorder, MDD, or other mood disorder (Familial Patterns).
- Quantify the impacts of exercise (a submaximal exercise test) on mood states and related domains by mood-disorder group in a controlled laboratory setting (Exercise).
- Explore potential correlates of the association between motor activity and mood states (Correlates).
Endpoints:
Primary Endpoints:
- Subjective mood and energy ratings assessed 4 times daily with EMA in ecological settings;
- Scores on standardized questionnaires of mood and mania/hypomania;
- Clinical rating scales;
- Within subject and group level averages and variability.
Secondary Endpoints:
- Subjective mood and energy ratings assessed with EMA before and after exercise;
- Clinical rating scales;
- Continuous heart rate measurements, blood pressure before and after (immediately, 0.5, 1,3, 12, and 24 hrs.) exercise.
Tertiary Endpoints:
Potential correlates of the association between motor activity and mood states including individual factors (e.g., age, sex, comorbidity, medical history), physiologic factors (e.g., heart rate, cortisol, light sensitivity), cognitive factors (e.g., performance on cognitive and neuroimaging tasks), and environmental factors (e.g., light, season, temperature).
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Community cohort of families |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scores on standardized questionnaires
Time frame: Every 6 months
Using standardized scales
Subjective mood and energy ratings
Time frame: 4x daily
Using EMA
Clinical rating scales
Time frame: Every 6 months
Using standardized scales
3 secondary outcomes
Continuous heart rate measurements, blood pressure
Time frame: Before and after exercise
Subjective mood and energy rating
Time frame: Before and after exercise
Clinical rating scales
Time frame: Before and after exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Our intention is to share aggregated data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen R Merikangas, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Major Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen R Merikangas, Ph.D. ((301) 496-7773, familystudy@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on standardized questionnaires (time frame: Every 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.