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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Exposure and Response Prevention
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Insitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine, Exposure & Response Prevention

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
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

Full Information

First Posted
February 12, 2014
Last Updated
November 8, 2016
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02062658
Brief Title
Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Official Title
Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine, Exposure & Response Prevention
Arm Type
Experimental
Arm Description
0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
0.5mg/kg IV
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Other Intervention Name(s)
EX/RP
Intervention Description
A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Primary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H Blair Simpson, MD, PhD
Organizational Affiliation
Columbia-NYSPI-RFMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Insitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27046314
Citation
Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138. No abstract available.
Results Reference
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Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

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