Actively Recruiting
Natural History of Depression, Bipolar Disorder and Suicide Risk
Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-29
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with mood disorders, including depression, bipolar disorder, and those at risk of suicide, to better understand how these conditions affect the body and how different treatments work. The study aims to identify predictors of response to antidepressant treatment and to find ways to predict which medications may help reduce thoughts of suicide. This observational study is conducted by the National Institute of Mental Health and involves participants who are already receiving clinical care for these conditions. Participants in this study are adults aged 18 years or older who have previously enrolled in a related protocol. They will undergo personalized treatments for their mood disorders and will be closely monitored through clinical ratings both in-person and remotely. The study includes three groups: individuals with bipolar disorder, individuals with major depressive disorder, and individuals at elevated suicide risk. The study typically lasts up to 12 weeks but may continue longer if treatment extends beyond this period. During the study, participants will have weekly interviews and complete questionnaires to assess their mood and suicidal thoughts. Optional tests such as psychological assessments, blood draws, sleep studies, and imaging scans are performed at the beginning and end of participation. The main outcomes measured are scores on the Montgomery Asberg Depression Rating Scale and the Scale for Suicidal Ideation, collected weekly. This helps researchers track treatment effects and understand the biological and clinical factors influencing response to therapy.
CONDITIONS
Brief Title
Natural History of Depression, Bipolar Disorder and Suicide Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers
- Age 18 years or older
- Able to provide informed consent
- Able to read and write English
You will not qualify if you...
- Unstable medical conditions that prevent participation in outpatient or inpatient treatment
- Pregnancy
- Participation as a healthy volunteer in Protocol 01-M-0254
- History of substance or alcohol abuse or dependence, or substance use disorder (except caffeine, nicotine, or cannabis), within the past three months
- Current use of illicit drugs (except caffeine, nicotine, or cannabis) within two weeks prior to consent, and positive drug urine test (except prescribed benzodiazepines or stimulants)
- Daily cannabis use, inability to abstain during the study, or cannabis use impairing daily life as determined by a clinician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies with individual treatment course
Participants undergo clinical ratings and assessments in-person and remotely throughout their standard clinical treatments for mood disorders and suicide risk.
Weekly visits (in-person or remote) for clinical assessments
Duration - At baseline and study termination
Neurobiological procedures are performed at baseline and at the end of the study to identify potential predictors and biomarkers of treatment response.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Kelly T Hurst, Ph.D.
E
Elizabeth D Ballard, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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