Long-term Observation of Participants With Mood Disorders

Last updated: November 26, 2025
Sponsor: National Institute of Mental Health (NIMH)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Depression

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT04877977
10000375
000375-M
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

  • 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 Patientswith 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

EXCLUSION CRITERIA:

None.

Study Design

Total Participants: 1000
Study Start date:
August 17, 2021
Estimated Completion Date:
October 01, 2028

Study Description

Study Description: The proposal will leverage existing data on former participants with mood disorders collected in the Experimental Therapeutics and Pathophysiology Branch in order to identify predictors of long-term depressive symptoms, suicide attempts and ketamine utilization. The ETPB has collected a wealth of clinical, biologic, neuroimaging and sleep data on individuals with treatment resistant depression and bipolar disorder over the last 20 years. This study would re-contact these individuals for online and telephone assessment of current symptoms. We would then determine the ability of these clinical and biological measures to predict long-term outcomes. For individuals who do not participate in online or telephone data collection, we would like to identify incidence of premature death, including suicide, using linkage to data sources such as the National Death Index. We will also use this protocol for recruitment for in-person neurobiological studies and clinical trials of treatment resistant depression, bipolar disorder and suicide risk, both for ETPB and other branches of the NIMH IRP.

Objectives: The primary objective is to identify predictors of long-term treatment-resistant depression. The secondary and tertiary objectives are to identify predictors of long-term risk for suicide attempt and identify predictors of repeat use of ketamine, respectively

Endpoints:

Primary Endpoint: Score on Beck Depression Inventory

Secondary Endpoint: Self-reported suicide attempt after NIH study participation

Secondary Endpoint: Self-reported ketamine utilization after NIH study participation

Secondary Endpoint: Suicide death as reported by the National Death Index

Study Population: The sample size will be up to 1000 participants who previously signed consent into Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers and will include participants 18 years and older, any gender and health status.

Description of Sites/Facilities Enrolling Participants: The study will be conducted online through a secure study website. Data collection can also occur over the phone.

Study Duration: 1 year

Participant Duration: 20 minutes- 4 hours

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • National Institutes of Health Clinical Center

    Bethesda 4348599, Maryland 4361885 20892
    United States

    Active - Recruiting

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