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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obsessive-Compulsive Disorder (OCD)

Intervention / Treatment
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* Drug: Rapastinel (formerly GLYX-13)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental:Rapastinel (formerly GLYX-13)<br>10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week. | Drug: Rapastinel (formerly GLYX-13)<br>* 10 mg/kg IV Rapastinel (formerly GLYX-13)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 230 minutes post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD