NCT02192099

Open Label Extension for GLYX13-C-202, NCT01684163

Phase 2, Open Label Extension for Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder Previously Treated With GLYX-13 (Extension of GLYX13-C-202, NCT01684163)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202.

Detailed description

Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202 in an open label extension trial.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Rapastinel (225 mg/450 mg IV administration)	Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel

Timeline

• Start date: 2014-09-08
• Primary completion: 2018-11-08
• Completion: 2018-11-08
• First posted: 2014-07-16
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

10 sites across 1 country: United States