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NCT03973268 · ClinicalTrials.gov registry record · Phase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
A Phase 1 study of Depression and Major Depressive Disorder, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT03973268 is a Phase 1 study of Depression and Major Depressive Disorder that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 70 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03973268, a Phase 1 study of Depression and Major Depressive Disorder, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Arm 1, 2, 3 device interventions
- OTHER Arm 2 Interventions
- DRUG Arm 1, 2, 3 drug Interventions
- DRUG Arm 1 and 2 Interventions
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03973268
The ClinicalTrials.gov registry entry for NCT03973268 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Arm 1, 2, 3 device interventions is the first listed.
NCT03973268 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03973268 about?
NCT03973268 is a clinical study titled "Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression". 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 antidepressan...
What is the current status of trial NCT03973268?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-01-21. Estimated completion is 2027-02-01.
What conditions does trial NCT03973268 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Major Depression.
What interventions are being tested in trial NCT03973268?
The interventions under investigation include: Arm 1, 2, 3 device interventions (DEVICE), Arm 2 Interventions (OTHER), Arm 1, 2, 3 drug Interventions (DRUG), Arm 1 and 2 Interventions (DRUG).
Who is sponsoring clinical trial NCT03973268?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03973268 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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