Phase 2
Completed N=7
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder (OCD)
Source: ClinicalTrials.gov NCT02267629 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. — 13.71 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. |
13.71 | — |
| SECONDARY Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02267629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.