Natural History of Depression, Bipolar Disorder and Suicide Risk

NCT06462196 | Recruiting

• 2 other identifiers: 10001874001874-M
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Central Nervous System Depressants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Ketamine; Depression, Unipolar; Depressive Symptoms; Treatment Resistant Depression; Major Depressive Disorder; Depression, Bipolar

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Score on Montgomery Asberg Depression Rating Scale

  Depression rating scale

  Weekly

Secondary Outcomes (1)

• Score on Scale for Suicide Ideation

  Weekly

Study Arms (3)

Bipolar Disorder

Individuals with Bipolar Disorder

Major Depressive Disorder

Individuals with Major Depressive Disorder

Suicide Risk

Individuals at an elevated suicide risk

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with depression, bipolar disorder, and individuals at elevated suicide risk.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Behavioral Symptoms; Suicide; Self-Injurious Behavior; Depressive Disorder; Depression; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavior; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Elizabeth D Ballard, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly T Hurst, Ph.D.

CONTACT

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

Elizabeth D Ballard, Ph.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 17, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-01-21

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting within 1 year of completion of the study
• Access Criteria: Participants data will only be shared if they have opted into the data share agreement. Data deposited into repositories will not be subject to any access, distribution, or reuse limitation beyond the standard procedures of the repository. Data will be uploaded to repositories listed in our NIH Intramural Research Program (IRP) Data Management and Sharing Plan. There are no restrictions on subsequent access, distribution, or reuse once the data is placed in a repository. The Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IRB.

Locations

US (1)