NCT03826693

Brief Summary

This study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of OCD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
17mo left

Started Apr 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Apr 2021Oct 2027

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 17, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

5.4 years

First QC Date

January 30, 2019

Last Update Submit

August 20, 2025

Conditions

Keywords

OCDnitrous oxide

Outcome Measures

Primary Outcomes (1)

  • Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.

    1 week

Study Arms (2)

Experimental: Nitrous Oxide

EXPERIMENTAL

OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.

Drug: Nitrous Oxide

Control: Nitrogen

PLACEBO COMPARATOR

OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Drug: Nitrogen

Interventions

OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.

Experimental: Nitrous Oxide

OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Control: Nitrogen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Primary diagnosis of OCD
  • Sufficient severity of OCD symptoms
  • Ability to tolerate a treatment-free period
  • Capacity to provide informed consent

You may not qualify if:

  • Psychiatric or medical conditions that make participation unsafe
  • Pregnant or nursing females
  • Concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Nitrous OxideNitrogen

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsElements

Study Officials

  • Peter J van Roessel, MD, PhD

    Stanford Univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavithra Mukunda, MS

CONTACT

Sindu Menon, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: placebo-controlled 2:1 randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

April 17, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations