Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder

New York State Psychiatric Institute

Status and phase

Completed

Phase 2

Conditions

Obsessive-Compulsive Disorder (OCD)

Treatments

Drug: Rapastinel (formerly GLYX-13)

Study type

Interventional

Funder types

Other

Identifiers

NCT02267629

#6986

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.