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Ketamine Clinical Trials

Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT03065335

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

Overal Status: Recruiting

Start Date: May 25, 2017

Last Update: May 4, 2021

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

• Healthy Volunteer
• Major Depressive Disorder
• Depression