Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: GLYX-13

• Registration Number: NCT01234558
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary

The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2011-05
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• diagnosis of major depressive disorder consistent with DSM-IV-TR
• current episode greater than 8 weeks in duration
• Hamilton Depression score >/- 21
• less than 25% reduction in depression during current episode assessed by ATRQ

Exclusion Criteria

• Axis diagnosis of other psychiatric disorders
• Experiencing hallucinations, delusions, other psychotic symptomatology
• ECT during current episode

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLYX-13, 5 mg/kg	GLYX-13	-
GLYX-13, 10 mg/kg	GLYX-13	-
Normal Saline	GLYX-13	IV placebo
GLYX-13, 1 mg/kg	GLYX-13	-

Primary Outcome Measures

Name	Time	Method
Change in depression score	14 days

Secondary Outcome Measures

Name	Time	Method
Change in BPRS+	14 days

Trial Locations

Locations (1)

Mulitple; 🇺🇸 Evanston, Illinois, United States