Natural History of Depression, Bipolar Disorder and Suicide Risk

Recruiting

• Conditions: Excitatory Amino Acid Agents; Molecular Mechanisms of Pharmacological Action; Anesthetics, Dissociative; Behavioral Symptoms; Suicide; Self-Injurious Behavior; Anesthetics; Depression, Unipolar; Depressive Symptoms; Depression, Bipolar

• Registration Number: NCT06462196
• Lead Sponsor: National Institute of Mental Health (NIMH)

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....

Detailed Description

Study Description:

This proposal would collect systematic data on individuals undergoing personalized treatments for depression, bipolar disorder and suicide risk within the Experimental Therapeutics and Pathophysiology Branch (ETPB). The ETPB recruits individuals with treatment-resistant mood disorders from around the country. After research participation, they are often offered a course of standard treatment, tailored to clinical needs, for clinical stabilization and discharge back to non-NIH clinicians. This protocol would allow for clinical ratings in-person and remotely throughout clinical standard treatments, as well as neurobiological procedures at baseline and study termination to identify potential clinical and demographic predictors and biomarkers of treatment response.

Objectives:

The primary objective is to identify predictors of antidepressant treatment response.

The secondary and tertiary objectives are to identify predictors of suicide ideation response to treatment, and biomarkers of antidepressant response to treatment, respectively.

Endpoints:

Primary Endpoint: Score on the Montgomery Asberg Depression Rating Scale

Secondary Endpoint: Score on the Scale for Suicidal Ideation

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-17
• Study Start: 2024-09-09
• Status Verified: 2025-04-08
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2030-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score on Montgomery Asberg Depression Rating Scale	Weekly	Depression rating scale

Secondary Outcome Measures

Name	Time	Method
Score on Scale for Suicide Ideation	Weekly	Scale for rating suicide ideation

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States