Natural History of Depression, Bipolar Disorder and Suicide Risk

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Elizabeth D Ballard, Ph.D.; Phone Number: (301) 435-9399; Email: elizabeth.ballard@nih.gov
• Study Contact Backup: Name: Kelly T Hurst, Ph.D.; Phone Number: (877) 646-3644; Email: moodresearch@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: Elizabeth Ballard, Ph.D.; Phone Number: 301-435-9399; Email: elizabeth.ballard@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Major Depressive Disorder; Individuals with Major Depressive Disorder
Bipolar Disorder; Individuals with Bipolar Disorder
Suicide Risk; Individuals at an elevated suicide risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Montgomery Asberg Depression Rating Scale	Depression rating scale	Weekly

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Scale for Suicide Ideation	Scale for rating suicide ideation	Weekly

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Elizabeth D Ballard, Ph.D., National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: January 21, 2026

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Suicide; Biomarkers; Neurobiology; Major Depressive Disorder; Treatment Resistant Depression; Suicide Risk
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Behavior; Suicide; Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 10001874; 001874-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical and research ratings, multi-modal MRI images, MEG scans, sleep studies, physiological, behavioral, and phenotypic data collected during the study, after deidentification.
• IPD Sharing Time Frame: Starting within 1 year of completion of the study
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No