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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder (OCD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: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.

Group Type EXPERIMENTAL

Rapastinel (formerly GLYX-13)

Intervention Type DRUG

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

Interventions

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Rapastinel (formerly GLYX-13)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No