Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Rapastinel (formerly GLYX-13)
Intervention description: 10 mg/kg IV Rapastinel (formerly GLYX-13)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: OCD

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.
    

Eligibility 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.