Long-term Observation of Participants With Mood Disorders

• ClinicalTrials.gov Identifier: NCT04877977
• Recruitment Status: Recruiting
• First Posted: May 7, 2021
• Last Update Posted: July 1, 2022
• Sponsor: National Institute of Mental Health (NIMH)
• 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

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 *

• Gilbert JR, Ballard ED, Galiano CS, Nugent AC, Zarate CA Jr. Magnetoencephalographic Correlates of Suicidal Ideation in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):354-363. doi: 10.1016/j.bpsc.2019.11.011. Epub 2019 Dec 3.
• Ballard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, Richards EM, Niciu MJ, Furey ML, Duncan WC Jr, Zarate CA Jr. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2016 Jun;77(6):825-31. doi: 10.4088/JCP.15m09943. Erratum in: J Clin Psychiatry. 2016 Dec;77(12):e1655.
• Nugent AC, Ballard ED, Gould TD, Park LT, Moaddel R, Brutsche NE, Zarate CA Jr. Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects. Mol Psychiatry. 2019 Jul;24(7):1040-1052. doi: 10.1038/s41380-018-0028-2. Epub 2018 Feb 27.

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

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