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

Obsessive-Compulsive Disorder (OCD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267629
• Other study ID #: #6986
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2014
• Last updated: January 3, 2017
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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, destropropoxyphene, 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, destropropoxyphene, or ketobemidone.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder (OCD)

Intervention

Drug:
• GLYX-13
10 mg/kg IV GLYX-13

Locations

Country	Name	City	State
United States	New York State Psychiatric Insitute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)		4 Weeks	No

External Links

•   Rodriguez Lab - Stanford University
•   Website for Study