Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

Brief Summary

This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.

Intervention / Treatment

  • Ketamine (DRUG)
    0.5mg/kg IV
  • Exposure and Response Prevention (BEHAVIORAL)
    A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.

Condition or Disease

  • Obsessive-Compulsive Disorder

Phase

  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 10 (ACTUAL)
    Funded by: Other|NIH
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Dec 01, 2013
    Primary Completion: Dec 01, 2015 ACTUAL
    Completion Date: Dec 01, 2015 ACTUAL
    Study First Posted: Feb 14, 2014 ESTIMATED
    Results First Posted: Oct 27, 2016 ESTIMATED
    Last Updated: Nov 08, 2016

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)

    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
    * Currently off all psychotropic medication OR
    * Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
    * Able to provide consent

    Exclusion Criteria:

    * Psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance dependence \[including nicotine\])
    * Female patients who are either pregnant or nursing
    * Planning to commence 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.

    period of the study

    * Allergy to ketamine
    * Participants for whom being off of medication is not clinically recommended
    * Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
    * Currently on medications that make participation unsafe

    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: NCT02062658
    Other IDs: #6811
    Study URL: https://clinicaltrials.gov/study/NCT02062658
    Last updated: Sep 29, 2023