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
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Organisation Name: National Institutes of Health Clinical Center (CC)
Overal Status: Recruiting
Start Date: January 21, 2020
Last Update: June 29, 2020
Lead Sponsor: National Institute of Mental Health (NIMH)
Brief Summary: Background:Conditions
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.
To see if the antidepressant response of ketamine is linked to AMPA receptors.
Adults ages 18-70 with major depression disorder without psychotic features
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:
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.
- Major Depressive Disorder
- Major Depression
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