Long-term Observation of Participants With Mood Disorders

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04877977
Collaborator
(none)
1,000
Enrollment
1
Location
23.4
Anticipated Duration (Months)
42.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Synopsis

    Title: Long-term Observation of Participants with Mood Disorders

    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. 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

    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 including both individuals with mood or anxiety disorders and healthy volunteers.

    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: 1.5 years

    Participant Duration: 20 minutes- 4 hours

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long-term Observation of Participants With Mood Disorders
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Jan 2, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    ArmIntervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Score on Beck Depression Inventory (suicide item removed) [Follow-up assessment]

      Rating of depression without assessment of suicidal ideation

    Secondary Outcome Measures

    1. Self-reported suicide attempt [Follow-up assessment]

      Self-reported suicide attempt since leaving NIH

    2. Ketamine utilization at non-NIH facility [Follow-up assessment]

      Participants will report whether they accessed ketamine/esketamine after leaving NIH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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

    4. Able to read and write English

    EXCLUSION CRITERIA:

    Participation in Protocol 15-M-0188 in Groups 1, 2, 3, or 5, as these participants are already contacted for follow-up evaluation.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Elizabeth D Ballard, Ph.D., National Institute of Mental Health (NIMH)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Mental Health (NIMH)
    ClinicalTrials.gov Identifier:
    NCT04877977
    Other Study ID Numbers:
    • 10000375
    • 000375-M
    First Posted:
    May 7, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Aug 19, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Mental Health (NIMH)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021