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

• ClinicalTrials.gov Identifier: NCT02267629
• Recruitment Status: Completed
• First Posted: October 17, 2014
• Results First Posted: May 10, 2017
• Last Update Posted: July 18, 2017
• Sponsor: New York State Psychiatric Institute
• Information provided by (Responsible Party): New York State Psychiatric Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder (OCD)	Drug: Rapastinel (formerly GLYX-13)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
• Study Start Date: October 2014
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. [ Time Frame: Baseline and 230 minutes post infusion ]
   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.

Secondary Outcome Measures :

1. Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [ Time Frame: Baseline and 4 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Insitute

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

• Principal Investigator: Carolyn I Rodriguez, MD, PhD; Stanford University

More Information

Additional Information:

Website for Study 

Rodriguez Lab - Stanford University 

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.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT02267629
• Other Study ID Numbers: #6986
• First Posted: October 17, 2014
• Results First Posted: May 10, 2017
• Last Update Posted: July 18, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:

OCD

Additional relevant MeSH terms:

Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Personality Disorders; Mental Disorders; Anxiety Disorders