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

Ketamine

Brief 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.

Intervention / Treatment

  • Intranasal ketamine (DRUG)
    A single dose of intranasal ketamine up to 50 mg
  • Intranasal midazolam (DRUG)
    A single dose of intranasal Midazolam up to 4 mg

Condition or Disease

  • Obsessive-Compulsive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 2 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2014
    Primary Completion: May 01, 2015 ACTUAL
    Completion Date: May 01, 2015 ACTUAL
    Study First Posted: Aug 01, 2014 ESTIMATED
    Results First Posted: Feb 23, 2017 ACTUAL
    Last Updated: Mar 30, 2017

    Sponsors / Collaborators

    Lead Sponsor: New York State Psychiatric Institute
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    Participant Groups

    • A single dose of intranasal midazolam up to 4 mg

    • A single dose of intranasal ketamine up to 50 mg

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Patients given 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 was defined as at least a 35% reduction on the YBOCS.

    More Details

    NCT Number: NCT02206776
    Other IDs: #6952
    Study URL: https://clinicaltrials.gov/study/NCT02206776
    Last updated: Sep 29, 2023