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Ketamine Clinical Trials

The Mechanism of Action Underlying Ketamine s Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression

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

Id: NCT03973268

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

Overal Status: Recruiting

Start Date: January 21, 2020

Last Update: December 4, 2020

Lead Sponsor: National Institute of Mental Health (NIMH)

Brief Summary: Background:

Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.

Objective:

To see if the antidepressant response of ketamine is linked to AMPA receptors.

Eligibility:

Adults ages 18-70 with major depression disorder without psychotic features

Design:

Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam.

Participants will stay at the NIH Clinical Center for 5 weeks.

Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests:

Blood draws
Psychological tests
MRI: Participants will lie in a machine that takes pictures of their brain.
MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity.
Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep.
Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity.

For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.

• Depression
• Major Depressive Disorder
• Major Depression