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Ketamine Clinical Trials

Long-term Observation of Participants With Mood Disorders

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Id: NCT04877977

Organisation Name: National Institutes of Health Clinical Center (CC)

Overal Status: Not yet recruiting

Start Date: July 28, 2021

Last Update: July 23, 2021

Lead Sponsor: National Institute of Mental Health (NIMH)

Brief Summary: 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


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

  • Depression
  • Suicide Risk

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