Ketamine Clinical Trials
Long-term Observation of Participants With Mood Disorders
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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: SynopsisConditions
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
Total execution time in seconds: 0.29284191131592