NCT04877977 Long-term Observation of Participants With Mood Disorders
| NCT ID | NCT04877977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-08-17 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-08-17 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Elizabeth D Ballard, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT04877977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04877977 currently recruiting?
Yes, NCT04877977 is actively recruiting participants. Contact the research team at elizabeth.ballard@nih.gov for enrollment information.
Where is the NCT04877977 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04877977 clinical trial?
NCT04877977 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Elizabeth D Ballard, Ph.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 1,000 participants.
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