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

Phase 2
Completed
Conditions
Obsessive-Compulsive Disorder
Interventions
Behavioral: Exposure and Response Prevention
Registration Number
NCT02062658
Lead Sponsor
New York State Psychiatric Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Ketamine, Exposure & Response PreventionExposure and Response Prevention0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine, Exposure & Response PreventionKetamine0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Primary Outcome Measures
NameTimeMethod
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale2 weeks

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York State Psychiatric Insitute

🇺🇸

New York, New York, United States

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