Obsessive-Compulsive Disorder
Conditions
Keywords
OCD
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.
Interventions
DRUGKetamine
0.5mg/kg IV
BEHAVIORALExposure and Response Prevention
A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | 2 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. |
Countries
United States
Participant flow
Recruitment details
Adult outpatients were recruited from the community starting March 2014 until March 2015.
Pre-assignment details
No pre-assignment was done.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine, Exposure & Response Prevention 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
Ketamine: 0.5mg/kg IV
Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ketamine, Exposure & Response Prevention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 35.3 years STANDARD_DEVIATION 10.6 |
| Gender Female | 1 Participants |
| Gender Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketamine, Exposure & Response Prevention | Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | 5 participants |