NCT01684163

Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants

Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. This trial will assess the effects of GLYX-13 on depression when added to another antidepressant drug that the patient is already taking.

Detailed description

To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal period).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	GLYX-13 5 mg/kg	Intravenous administration of 5 mg/kg into arm.
DRUG	GLYX-13 10 mg/kg	Intravenous administration of 10 mg/kg into arm.
DRUG	Placebo	Intravenous administration of normal saline into arm.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2012-09-12
• Last updated: 2016-03-17

Locations

26 sites across 1 country: United States