Long-term Observation of Participants With Mood Disorders

Study Overview
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Brief Summary
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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
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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

Official Title
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Long-term Observation of Participants With Mood Disorders

Conditions
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Depression, Suicide Risk

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 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. Age 18 years or older Able to provide informed consent online using study website or over the telephone Able to read and write English EXCLUSION CRITERIA: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Individuals who previously signed consent for ETPB research as healthy volunteers | |
| Mood Disorder Patients<br>Individuals with mood disorders who previously signed consent for ETPB research | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Suicide, Ketamine, Neuroimaging, Treatment Resistant Depression, Natural History