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NCT02122562 · ClinicalTrials.gov registry record · Phase 2
Ketamine Alcohol (in Treatment-Resistant Depression)
A Phase 2 study of Alcoholism and Major Depression, sponsored by Mark Niciu.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02122562 is a Phase 2 study of Alcoholism and Major Depression that is actively recruiting participants, run by Mark Niciu. The registered enrollment target is 60 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02122562, a Phase 2 study of Alcoholism and Major Depression, is actively recruiting participants, sponsored by Mark Niciu.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of the strongest identified predictors of an improved antidepressant response to ketamine. Like ketamine, alcohol is a functional NMDA receptor antagonist. FHP is associated with differential response to ketamine, e.g. blunted psychotomimetic side effects. One of the primary mechanistic hypotheses for ketamine's antidepressant action is the acute intrasynaptic release of glutamate from major output neurons, e.g. cortical pyramidal cells. Preliminary clinical studies have demonstrated this acute glutamate "surge" in response to subanesthetic dose ketamine. Based on these findings, the investigators hypothesize that ketamine's enhanced antidepressant efficacy in FHP TRD subjects is, at least in part, attributable to increased glutamate release relative to TRD subjects without a family history of alcohol use disorder (Family History Negative, FHN). To test this hypothesis, the investigators have designed a now two-site, open-label study of 18-55-year-old medically and neurologically healthy, currently moderately-to-severely depressed TRD patients. In total, the investigators plan to recruit 25 FHP and 25 FHN TRD subjects. All subjects must not have a current substance use disorder (except nicotine or caffeine). The experimental portion consists of two phases. The preliminary first phase is a medication taper (if needed) and psychotropic medication-free period. The experimental second phase comprises one subanesthetic dose (0.5mg/kg x 40 minute) ketamine infusion. The ketamine infusion will occur during 7T-magnetic resonance imaging (MRI), both resting-state functional MRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) to detect glutamate in the ventromedial prefrontal cor
Conditions Studied
Interventions
- DRUG Ketamine
Study Locations (1)
Iowa
- University of Iowa Health Care - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-04-23 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02122562
The ClinicalTrials.gov registry entry for NCT02122562 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (84% lower). The listed sponsor is Mark Niciu, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alcoholism appearing as the primary indexed condition, and to 1 intervention - of which Ketamine is the first listed.
NCT02122562 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT02122562 about?
NCT02122562 is a clinical study titled "Ketamine Alcohol (in Treatment-Resistant Depression)". A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of...
What is the current status of trial NCT02122562?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-04-23. Estimated completion is 2026-09.
What conditions does trial NCT02122562 study?
This clinical trial studies the following conditions: Alcoholism, Major Depression, Magnetic Resonance Imaging.
What interventions are being tested in trial NCT02122562?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT02122562?
This trial is sponsored by Mark Niciu, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02122562 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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