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Trial Outcomes & Findings for Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder (NCT NCT02267629)

NCT ID: NCT02267629

Last Updated: 2017-07-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline and 230 minutes post infusion

Results posted on

2017-07-18

Participant Flow

Participant milestones

Participant milestones
Measure
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)
Overall Study
STARTED
7
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental:Rapastinel (Formerly GLYX-13)
n=7 Participants
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)
Age, Continuous
36 years
STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Experimental:Rapastinel (Formerly GLYX-13)
n=7 Participants
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)
Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.
13.71 units on a scale
Standard Deviation 6.47

SECONDARY outcome

Timeframe: Baseline and 4 Weeks

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.

Outcome measures

Outcome measures
Measure
Experimental:Rapastinel (Formerly GLYX-13)
n=7 Participants
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)
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
0 Participants

Adverse Events

Experimental:Rapastinel (Formerly GLYX-13)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carolyn Rodriguez, Assistant Professor, Director of Rodriguez Translational Therapeutics Lab

Stanford University

Phone: 650-723-6158

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place