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

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

Topic Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published
Start date 21 January 2020
End date 01 February 2025
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 70
Sex All
Age 18- 70
Therapy No

Trial Details

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.

Trial Number NCT03973268

Sponsors & Collaborators

National Institute of Mental Health
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National Institutes of Health Clinical Center
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Data attribution

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