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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder (OCD)
• Intervention / Treatment: Drug: Rapastinel (formerly GLYX-13)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Insitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental:Rapastinel (formerly GLYX-13); 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); 10 mg/kg IV Rapastinel (formerly GLYX-13)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute

Publications and helpful links

General Publications

• Rodriguez CI, Zwerling J, Kalanthroff E, Shen H, Filippou M, Jo B, Simpson HB, Burch RM, Moskal JR. Effect of a Novel NMDA Receptor Modulator, Rapastinel (Formerly GLYX-13), in OCD: Proof of Concept. Am J Psychiatry. 2016 Dec 1;173(12):1239-1241. doi: 10.1176/appi.ajp.2016.16080868. No abstract available.

Helpful Links

• Rodriguez Lab - Stanford University
• Website for Study

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (ESTIMATE): October 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: OCD
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: #6986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO