Overview

This trial is active, not recruiting.

Condition obsessive-compulsive disorder
Treatments ketamine, exposure and response prevention
Phase phase 2
Sponsor New York State Psychiatric Institute
Collaborator National Institute of Mental Health (NIMH)
Start date December 2013
End date December 2015
Trial size 15 participants
Trial identifier NCT02062658, #6811, K23MH092434

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
ketamine Ketamine hydrochloride
0.5mg/kg IV
exposure and response prevention EX/RP
A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.

Primary Outcomes

Measure
Improvement in severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)
Principal investigator H Blair Simpson, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.