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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02062658
• Other study ID #: #6811
• Secondary ID: K23MH092434
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: August 27, 2015
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2015
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Ketamine
0.5mg/kg IV

Behavioral:
• Exposure and Response Prevention
A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.

Locations

Country	Name	City	State
United States	New York State Psychiatric Insitute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)		4 weeks	No