Natural History of Depression, Bipolar Disorder and Suicide Risk

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT06462196
Status
Recruiting

Conditions

  • Analgesics
  • Anesthetics
  • Anesthetics, Dissociative
  • Anesthetics, General
  • Behavioral Symptoms
  • Central Nervous System Depressants
  • Depression, Bipolar
  • Depression, Unipolar
  • Depressive Symptoms
  • Excitatory Amino Acid Agents
  • Excitatory Amino Acid Antagonists
  • Ketamine
  • Major Depressive Disorder
  • Molecular Mechanisms of Pharmacological Action
  • Neurotransmitter Agents
  • Peripheral Nervous System Agents
  • Physiological Effects of Drugs
  • Self-Injurious Behavior
  • Sensory System Agents
  • Suicide
  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Study Details

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.

Key Dates

Start date
Sep 9, 2024
Status verified
Jan 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Bipolar Disorder
    Individuals with Bipolar Disorder
  • Arm: Major Depressive Disorder
    Individuals with Major Depressive Disorder
  • Arm: Suicide Risk
    Individuals at an elevated suicide risk

Primary Outcome Measure

Score on Montgomery Asberg Depression Rating Scale [ Time Frame: Weekly ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Elizabeth Ballard, Ph.D.
301-435-9399

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