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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 274 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Jun 12, 2026, no change to tracked fieldsv272-v274
  2. Primary and study completion dates: Feb 1, 2026 to Feb 1, 2027v271
  3. 7 versions Re-verified since Mar 10, 2025, no change to tracked fieldsv264-v270
  4. Primary and study completion dates: Feb 1, 2025 to Feb 1, 2026v263
  5. Site contact updatedv262
Show 37 earlier versionsHide 37 earlier versions
  1. Re-verified, no change to tracked fieldsv261
  2. Study Status, Contacts/Locationsv260
  3. 3 versions Re-verified since Aug 31, 2024, no change to tracked fieldsv257-v259
  4. Study Status, Eligibilityv256
  5. 6 versions Re-verified since Aug 19, 2023, no change to tracked fieldsv250-v255
  6. Interventions: Arm 1 and 2 Interventions (Drug), Arm 1, 2, 3 Interventions (Drug), Arm 1, 2, 3 interventions (Device), Arm 2 Interventions (Other) to Arm 1 and 2 Interventions (Drug), Arm 1, 2, 3 device interventions (Device), Arm 1, 2, 3 drug Interventions (Drug), Arm 2 Interventions…v249
  7. 24 versions Re-verified since Jun 2, 2022, no change to tracked fieldsv225-v248
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03973268
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Depression, Major Depressive Disorder, Major Depression
Related terms Depression, Major Depressive Disorder
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov