Trial | NCT01234558  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    115
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
Study Started
May 31
2011
Primary Completion
Jun 30
2012
Study Completion
Jul 31
2012
Last Update
Sep 12
2012
Estimate

Drug GLYX-13

single IV dose

  • Other names: ThrProProThr

GLYX-13, 10 mg/kg Experimental

Normal Saline Placebo Comparator

IV placebo

GLYX-13, 1 mg/kg Experimental

GLYX-13, 5 mg/kg Experimental

Criteria 

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
No Results Posted