Clinical trial NCT02267629: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder (OCD)
Keywords: OCD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.
timeFrame: Baseline and 230 minutes post infusion
Secondary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
timeFrame: Baseline and 4 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Insitute
state: New York
Study officials:
affiliation: Stanford University
name: Carolyn I Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.