NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: 70 Years

Referral Letter Required


Population Exclusion(s)



Mood Disorders;
Ecological Momentary Assessments;
Natural History

Recruitment Keyword(s)



Bipolar Disorder;
Major Depression;

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Mental Health


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.


To better understand relationships among physical activity, sleep, and mental health.


People aged 12 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.


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.

--Back to Top--



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 12-60

3. Probands must agree to direct evaluation (in either the outpatient or inpatient component) at the NIH Clinical Center

4. Probands must have at least one first-degree relative agree to participate

5. Affected probands must have a lifetime history of a mood disorder

6. Unaffected probands must have no lifetime history of a mood disorder

7. In good general health as evidenced by medical history

8. Agreement to adhere to Lifestyle Considerations throughout study duration

9. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.


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. Liver disease or ALT serum level greater than two times the laboratory upper limit of normal

2. Abnormal kidney function (eGFR<60 ml/min/1.73m^2)

3. Pregnancy

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

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Kathleen Merikangas, Ph.D.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 35
Room 1A201
15 North Drive
Bethesda, Maryland 20892
(301) 496-7773

Kathleen Merikangas, Ph.D.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 35
Room 1A201
15 North Drive
Bethesda, Maryland 20892
(301) 496-7773

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


--Back to Top--