Long-term Observation of Participants With Mood Disorders

NCT04877977 | Recruiting

• 2 other identifiers: 10000375000375-M
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments. Objective: To learn the long-term impact of depression, bipolar disorder, and suicide risk. Eligibility: Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago. Design: This study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact. In Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview. In Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH. In both phases, participants can skip any questions they do not want to answer. The online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours. The information that participants give in this study may be linked to their other NIH research records.

Conditions

Depression; Suicide Risk

Keywords

Depression; Suicide; Ketamine; Neuroimaging; Treatment Resistant Depression; Natural History

Outcome Measures

Primary Outcomes (1)

• Score on Beck Depression Inventory (suicide item removed)

  Rating of depression without assessment of suicidal ideation

  Follow-up assessment

Secondary Outcomes (3)

• Ketamine utilization at non-NIH facility

  Follow-up assessment

• Self-reported suicide attempt

  Follow-up assessment

• Identify predictors of death by suicide

  Follow-up assessment

Study Arms (2)

Healthy Volunteers

Individuals who previously signed consent for ETPB research as healthy volunteers

Mood Disorder Patients

Individuals with mood disorders who previously signed consent for ETPB research

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study involves re-contacting former participants of 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers for participation in this follow-up study.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago.
• Age 18 years or older
• Able to provide informed consent online using study website or over the telephone
• Able to read and write English

You may not qualify if:

• None.

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 Publications (4)

• Gilbert JR, Ballard ED, Galiano CS, Nugent AC, Zarate CA Jr. Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):354-363. doi: 10.1016/j.bpsc.2019.11.011. Epub 2019 Dec 3.

  PMID: 31928949 BACKGROUND

• Ballard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, Richards EM, Niciu MJ, Furey ML, Duncan WC Jr, Zarate CA Jr. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2016 Jun;77(6):825-31. doi: 10.4088/JCP.15m09943.

  PMID: 27337418 BACKGROUND

• Nugent AC, Ballard ED, Gould TD, Park LT, Moaddel R, Brutsche NE, Zarate CA Jr. Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects. Mol Psychiatry. 2019 Jul;24(7):1040-1052. doi: 10.1038/s41380-018-0028-2. Epub 2018 Feb 27.

  PMID: 29487402 BACKGROUND

• Hurst KT, Vogeley A, Greenstein DK, Durland L, Makel S, Wang PR, Yavi M, Zarate CA Jr, Ballard ED. Long-term follow-up of participants in ketamine clinical trials for mood disorders. J Affect Disord. 2024 Jul 15;357:134-137. doi: 10.1016/j.jad.2024.04.062. Epub 2024 Apr 22.

  PMID: 38653350 DERIVED

MeSH Terms

Conditions

Depression; Suicide; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Elizabeth D Ballard, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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: May 6, 2021
• First Posted: May 7, 2021
• Study Start: August 17, 2021
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11-25

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting within 1 year of completion of the study
• Access Criteria: Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IIRB.

Locations

US (1)