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TerminatedPhase 2Results posted

Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD

NCT02206776 · New York State Psychiatric Institute

Closed to entry
Status
Not accepting participants
Phase 2
Phase
2
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.

    Measured over Baseline and 1 Week

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 55 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age 18-55 * Physically healthy and not currently pregnant * Primary diagnosis of OCD * Sufficient severity of symptoms * For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses. * Able to provide consent Exclusion Criteria: * First degree relative with schizophrenia * Psychiatric conditions that would make participation unsafe determined by study doctor * Female patients who are either pregnant or nursing * Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment. * Nasal obstruction or history of nasal surgery * Currently on psychotropic medication or other medication likely to interact with the glutamate system * Medical conditions that make participation unsafe * Allergy or intolerance to ketamine or midazolam

Where

1 study site

FacilityCityRegionCountry
New York State Psychiatric InstituteNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02206776 on ClinicalTrials.gov →

Last updated in the registry 2017-05-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 12 trials from New York State Psychiatric Institute →