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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute

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.