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

Primary Purpose

Obsessive-Compulsive Disorder (OCD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rapastinel (formerly GLYX-13)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder (OCD) focused on measuring OCD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York State Psychiatric Insitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental:Rapastinel (formerly GLYX-13)

Arm Description

10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2014
Last Updated
June 20, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02267629
Brief Title
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Official Title
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder (OCD)
Keywords
OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental:Rapastinel (formerly GLYX-13)
Arm Type
Experimental
Arm Description
10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.
Intervention Type
Drug
Intervention Name(s)
Rapastinel (formerly GLYX-13)
Intervention Description
10 mg/kg IV Rapastinel (formerly GLYX-13)
Primary Outcome Measure Information:
Title
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.
Description
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.
Time Frame
Baseline and 230 minutes post infusion
Secondary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Description
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.
Time Frame
Baseline and 4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I Rodriguez, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Insitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27903098
Citation
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.
Results Reference
background
Links:
URL
http://www.columbia-ocd.org
Description
Website for Study
URL
http://rodriguezlab.stanford.edu
Description
Rodriguez Lab - Stanford University

Learn more about this trial

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

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