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NCT02994433 · ClinicalTrials.gov registry record · Phase 1
NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits
A Phase 1 study, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02994433: Recruiting Phase 1 study, sponsored by Washington University School of Medicine.
NCT02994433 is a Phase 1 study that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02994433, a Phase 1 study, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This application proposes to take the next important step in understanding how nitrous oxide exerts its effects in the human brain by using state-of-the-art brain neuroimaging (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy volunteers and comparing the results to a group of TRMD patients. This study involves exposing approximately 25 non-depressed healthy participants and 25 TRMD participants to nitrous oxide and a placebo gas, to compare their brain images before and after each of the inhalation sessions. Sessions will be separated by at least one month to prevent treatment effects from carrying over into the following session. All willing and eligible subjects will undergo up to six functional connectivity MRI scans, and two inhalation sessions. Functional imaging in the brain will allow us to trace the interconnections between various parts of the brain, including those involved with emotion and depression. Other procedures will involve screening materials to ensure safety of the participants before beginning the study (i.e. no MRI scan contraindications) and that subjects meet eligibility criteria to being in the targeted age range, depression/non-depressed state, neurological disorder history, and no medication exclusions.
Primary Outcome
Functional connectivity is measured between groups after inhaling nitrous oxide/placebo using an individual seed-voxel z map and pared t-test group analysis to identify effects on inter-regional connectivity.
Interventions
- DEVICE MRI
- DRUG Nitrous Oxide
- DRUG Placebo gas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT02994433 shows while recruiting
NCT02994433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which MRI is the first listed.
NCT02994433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02994433 about?
NCT02994433 is a clinical study titled "NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits". Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and o...
What is the current status of trial NCT02994433?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-01-27. Estimated completion is 2027-04-30.
What interventions are being tested in trial NCT02994433?
The interventions under investigation include: MRI (DEVICE), Nitrous Oxide (DRUG), Placebo gas (DRUG).
Who is sponsoring clinical trial NCT02994433?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02994433's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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