Long-term Observation of Participants With Mood Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Suicide Risk

Detailed Description

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. For individuals who do not participate in online or telephone data collection, we would like to identify incidence of premature death, including suicide, using linkage to data sources such as the National Death Index. 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

Secondary Endpoint: Suicide death as reported by the National Death Index

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.

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 year

Participant Duration: 20 minutes- 4 hours

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Elizabeth D Ballard, Ph.D.; Phone Number: (301) 435-9399; Email: elizabeth.ballard@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: Elizabeth Ballard, Ph.D.; Phone Number: 301-435-9399; Email: elizabeth.ballard@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Beck Depression Inventory (suicide item removed)	Rating of depression without assessment of suicidal ideation	Follow-up assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported suicide attempt	Self-reported suicide attempt since leaving NIH	Follow-up assessment
Ketamine utilization at non-NIH facility	Participants will report whether they accessed ketamine/esketamine after leaving NIH	Follow-up assessment

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 8, 2024

More Information

Terms related to this study

• Keywords: Depression; Natural History; Ketamine; Suicide; Neuroimaging; Treatment Resistant Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Self-Injurious Behavior; Depression; Suicide; Mood Disorders
• Other Study ID Numbers: 10000375; 000375-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .Clinical and demographic and biomarker participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Starting within 1 year of completion of the study
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No