Ketamine Clinical Trials
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
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Id: NCT03065335
Organisation Name: National Institutes of Health Clinical Center (CC)
Overal Status: Recruiting
Start Date: May 25, 2017
Last Update: July 7, 2022
Lead Sponsor: National Institute of Mental Health (NIMH)
Brief Summary: Background:
Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.
Objective:
Main Study: To study the effects of ketamine in treating depression.
Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry.
To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.
Eligibility:
Main Study: People ages 18-65 with major depressive disorder and healthy volunteers
Ketamine Metabolites Substudy: Healthy volunteers ages 18-65
Design:
Main Study:
Participants will be screened in another study, with:
Medical and psychiatric history
Psychiatric and physical exam
Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.
Phase I (2-7 weeks):
Gradually stop current medications
MRI: Participants lie and perform tasks in a machine that takes pictures of the body.
Mood and thinking tests
Blood and urine tests
Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.
Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.
Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.
Phase I tests are repeated in Phases II and III and in the final visit.
Phase II (4-5 weeks):
4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.
Phase III (optional):
8 infusions of ketamine over 4 weeks
Phase IV (optional):
Symptoms monitoring for 4 weeks
Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.
Ketamine Metabolites Substudy:
Participants will be screened in another study, with:
Medical and psychiatric history
Psychiatric and physical exam
Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 days.
Study Procedures:
Mood and thinking tests
Blood and urine tests
1 infusion of ketamine
Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry
Conditions:
- Healthy Volunteer
- Major Depressive Disorder
- Depression
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