NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02994433
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Nitrous Oxide — DRUG
    Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at 50% nitrous oxide/50% oxygen in this study.
  • Placebo gas — DRUG
    Placebo gas given at 50% nitrogen \[inert\]/50% oxygen.
  • MRI — DEVICE
    MRIs done on all participants, this is a tool we are using to measure outcomes. No treatment is from an MRI.

Study Details

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.

Key Dates

Start date
Jan 27, 2017
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Nitrous Oxide
    One hour inhalation of nitrous oxide
  • Placebo Comparator: Placebo Gas
    One hour inhalation of placebo gas

Primary Outcome Measure

Comparison of functional connectivity between default mode network of treatment-resistant depressed and non-depressed participants [ Time Frame: 2 hours after inhalation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Britt Gott, MS
[email protected]
314-362-2463
Charles R Conway, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Washington University School of Medicine· St Louis, MO

Related Studies