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.
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
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:
New York State Psychiatric Institute
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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
* 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
More Details
| NCT Number: | NCT02062658 |
|---|---|
| Other IDs: | #6811 |
| Study URL: | https://clinicaltrials.gov/study/NCT02062658 |
Last updated: Sep 29, 2023