Obsessive-Compulsive Disorder (OCD)
Conditions
Keywords
OCD
Brief summary
This research study tests whether GLYX-13 - an experimental drug that acts on a brain receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to a class of medications that target the NMDA brain receptor.
Interventions
DRUGRapastinel (formerly GLYX-13)
10 mg/kg IV Rapastinel (formerly GLYX-13)
Sponsors
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
for Patients with No medication Washout: * Age 18-55 * Physically healthy and not currently pregnant * Primary Diagnosis of OCD * currently off all psychotropic medications and other drugs * Able to provide informed consent
Exclusion criteria
for Patients with No Medication Washout: * 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 abuse in prior year\[including nicotine\], lifetime substance dependence disorder \[except nicotine\]) * Female patients who are either pregnant or nursing * Enrolled in or planning to enroll in Cognitive Behavioral Therapy. * Medical conditions that make participation unsafe (e.g., high blood pressure, head injury) * Currently on medications that make participation unsafe * History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone. Inclusion Criteria for Patients with Medication Washout: * Age 18-55 * Physically healthy and not currently pregnant * Primary Diagnosis of OCD * Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission and able to handle a medication washout. * Able to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. | Baseline and 230 minutes post infusion | Patients self-rated the severity of their obsessions and compulsions using the YBOC Challenge Scale, a 10-item self-report form that assesses Obsessive Compulsive Disorder (OCD) symptoms (i.e., time spent, degree of control, severity) \[total score range = 0 - 40 \] over the previous 60 minutes. The higher the number on the YBOCCS, the more severe the symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. | Baseline and 4 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
Participants by arm
| Arm | Count |
|---|---|
| Experimental:Rapastinel (Formerly GLYX-13) 10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13) | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Experimental:Rapastinel (Formerly GLYX-13) |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.
Patients self-rated the severity of their obsessions and compulsions using the YBOC Challenge Scale, a 10-item self-report form that assesses Obsessive Compulsive Disorder (OCD) symptoms (i.e., time spent, degree of control, severity) \[total score range = 0 - 40 \] over the previous 60 minutes. The higher the number on the YBOCCS, the more severe the symptoms.
Time frame: Baseline and 230 minutes post infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental:Rapastinel (Formerly GLYX-13) | Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. | 13.71 units on a scale | Standard Deviation 6.47 |
Secondary
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: Baseline and 4 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental:Rapastinel (Formerly GLYX-13) | Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. | 0 Participants |