Recruiting

Mental Health Follow-Up

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT04877977

Conditions

Depression

Suicide Risk

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04877977

Start date

Aug 17, 2021

Status verified date

Nov 25, 2025

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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

1. 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.
2. Age 18 years or older
3. Able to provide informed consent online using study website or over the telephone
4. Able to read and write English

EXCLUSION CRITERIA:

None.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Score on Beck Depression Inventory (suicide item removed) [ Time Frame: Follow-up assessment ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Nov 28, 2025

Last verified

Nov 25, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2025-11-28.