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NCT01234558 Clinical Trial

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

Major Depressive Disorder Clinical Trial

Official title:
Randomized, Double Blind, Placebo Controlled, Single IV Dose Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01234558
Other study ID # GLYX13-C201
Secondary ID
Status Completed
Phase Phase 2
First received November 3, 2010
Last updated September 10, 2012
Start date May 2011
Est. completion date July 2012

Study information
Verified date September 2012
Source Naurex, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date July 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• GLYX-13
single IV dose

Locations
Country Name City State
United States Mulitple Evanston Illinois

Sponsors (1)
Lead Sponsor Collaborator
Naurex, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in depression score 14 days
Secondary Change in BPRS+ 14 days
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