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

NCT02267629 | Completed Phase 2 Results DMC

• 1 other identifier: #6986
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and 4 Weeks

Study Arms (1)

Experimental:Rapastinel (formerly GLYX-13)

EXPERIMENTAL

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)

Interventions

Rapastinel (formerly GLYX-13) DRUG

10 mg/kg IV Rapastinel (formerly GLYX-13)

Experimental:Rapastinel (formerly GLYX-13)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Insitute

New York, New York, 10032, United States

Location

Related 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. doi: 10.1176/appi.ajp.2016.16080868. No abstract available.

  PMID: 27903098 BACKGROUND

Related Links

• Website for Study
• Rodriguez Lab - Stanford University

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

GLYX-13 peptide

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Carolyn Rodriguez, Assistant Professor, Director of Rodriguez Translational Therapeutics Lab
• Organization: Stanford University

cr2163@stanford.edu

650-723-6158

Study Officials

• Carolyn I Rodriguez, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 18, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)