Recruiting

Observational Study

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT06462196

Conditions

Behavioral Symptoms

Suicide

Self-Injurious Behavior

Sensory System Agents

Analgesics

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Behavioral Symptoms

Suicide

Self-Injurious Behavior

Sensory System Agents

Analgesics

Study ID

NCT06462196

Start date

Sep 9, 2024

Status verified date

Sep 29, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • 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

EXCLUSION CRITERIA:

  • Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.
  • Pregnancy
  • Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.
  • Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Bipolar Disorder

Individuals with Bipolar Disorder

Major Depressive Disorder

Individuals with Major Depressive Disorder

Suicide Risk

Individuals at an elevated suicide risk

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kelly T Hurst, Ph.D.

(877) 646-3644moodresearch@mail.nih.gov

Elizabeth D Ballard, Ph.D.

(301) 435-9399elizabeth.ballard@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Elizabeth Ballard, Ph.D.

301-435-9399elizabeth.ballard@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Oct 1, 2026

Last verified

Sep 29, 2026

Keywords

  • Neurobiology
  • Suicide
  • Major Depressive Disorder
  • Bipolar Disorder
  • Biomarkers
  • Suicide Risk
  • Treatment Resistant Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.