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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel (formerly GLYX-13) | Drug | 10 mg/kg IV Rapastinel (formerly GLYX-13) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Patients with No medication Washout:
Exclusion Criteria for Patients with No Medication Washout:
Inclusion Criteria for Patients with Medication Washout:
Exclusion Criteria for Patients with Medication Washout:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn I Rodriguez, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Insitute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27903098 | Background | 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. |
| Label | URL |
|---|---|
| Website for Study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 230 minutes post infusion |
|
over one week post infusion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Rodriguez, Assistant Professor, Director of Rodriguez Translational Therapeutics Lab | Stanford University | 650-723-6158 | cr2163@stanford.edu |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
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| Baseline and 4 Weeks |
| Rodriguez Lab - Stanford University | View source |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Baseline and 4 Weeks |
|
|
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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