Status:
COMPLETED
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Obsessive-Compulsive Disorder (OCD)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- Exclusion Criteria for Patients with 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.
- Patient judged unlikely to be able to tolerated a medication washout.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02267629
Start Date
October 1 2014
End Date
February 1 2016
Last Update
July 18 2017
Active Locations (1)
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1
New York State Psychiatric Insitute
New York, New York, United States, 10032