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Long-term Observation of Participants With Mood Disorders

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ClinicalTrials.gov Identifier: NCT04877977
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date May 6, 2021
First Posted Date May 7, 2021
Last Update Posted Date July 1, 2022
Estimated Study Start Date July 6, 2022
Estimated Primary Completion Date January 2, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2021)
Score on Beck Depression Inventory (suicide item removed) [ Time Frame: Follow-up assessment ]
Rating of depression without assessment of suicidal ideation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2021)
  • Self-reported suicide attempt [ Time Frame: Follow-up assessment ]
    Self-reported suicide attempt since leaving NIH
  • Ketamine utilization at non-NIH facility [ Time Frame: Follow-up assessment ]
    Participants will report whether they accessed ketamine/esketamine after leaving NIH
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Observation of Participants With Mood Disorders
Official Title Long-term Observation of Participants With Mood Disorders
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study involves re-contacting former participants of 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers for participation in this follow-up study.
Condition
  • Depression
  • Suicide Risk
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2021)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2023
Estimated Primary Completion Date January 2, 2023   (Final data collection date for primary outcome measure)
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
  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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Elizabeth D Ballard, Ph.D. (301) 435-9399 elizabeth.ballard@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04877977
Other Study ID Numbers 10000375
000375-M
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: .Clinical and demographic and biomarker participant data collected during the trial, after deidentification.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Starting within 1 year of completion of the study
Access Criteria: Branch Chief will review requests and access will need to be approved by the NIMH/DIRP SD and OCD NIMH and the NIH IIRB.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Original Responsible Party Same as current
Current Study Sponsor National Institute of Mental Health (NIMH)
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Elizabeth D Ballard, Ph.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 25, 2022