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

Phase 2

Completed

• Conditions: Obsessive-Compulsive Disorder (OCD)
• Interventions: Drug: Rapastinel (formerly GLYX-13)

• Registration Number: NCT02267629
• Lead Sponsor: New York State Psychiatric Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-03-30
• Results First Submitted QC: 2017-03-30
• Results First Posted: 2017-05-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental:Rapastinel (formerly GLYX-13)	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.

Primary Outcome Measures

Name	Time	Method
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.	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

Name	Time	Method
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.	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.

Trial Locations

Locations (1)

New York State Psychiatric Insitute; 🇺🇸 New York, New York, United States