Long-term Observation of Participants With Mood Disorders

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT04877977
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Aug 17, 2021
Status verified
Nov 2025
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Healthy Volunteers
    Individuals who previously signed consent for ETPB research as healthy volunteers
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Elizabeth Ballard, Ph.D.
[email protected]
301-435-9399

Find similar trials in Bethesda, MD

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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