Obsessive-Compulsive Disorder (OCD)Phase 2NCT02267629
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
A Phase 2 study testing Rapastinel (formerly GLYX-13) in people with Obsessive-Compulsive Disorder (OCD), run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- Rapastinel (formerly GLYX-13)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Insitute
New York, New York, 10032
About this study
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)
- Being tested
- Rapastinel (formerly GLYX-13)
- Keywords
- OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapastinel (formerly GLYX-13)Drug
10 mg/kg IV Rapastinel (formerly GLYX-13)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rapastinel (formerly GLYX-13) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 230 minutes post infusion
Secondary outcomes (1)
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
Measured: Baseline and 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn I Rodriguez, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267629
- Sponsor's protocol ID
- #6986
- Status last verified
- Jun 2017
- First submitted
- 14 Oct 2014
- Last updated
- 18 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27903098
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02267629
- Acronym / sponsor ID
- #6986
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- OCD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:Rapastinel (formerly GLYX-13) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapastinel (formerly GLYX-13)10 mg/kg IV Rapastinel (formerly GLYX-13) | Drug | Experimental:Rapastinel (formerly GLYX-13) |
Primary outcome
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.
Time frame: Baseline and 230 minutes post infusion
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.
1 secondary outcome
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Time frame: Baseline and 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27903098Rodriguez 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.
- Website for StudyLink provided by the sponsor.
- Rodriguez Lab - Stanford UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn I Rodriguez, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rapastinel (formerly GLYX-13) in people with Obsessive-Compulsive Disorder (OCD), run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion. (time frame: Baseline and 230 minutes post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.