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OpenTrials
Completed

NCT Number: NCT01234558

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

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

Completed

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mulitple

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLYX-13

Drug

single IV dose

Other names: ThrProProThr

Primary outcomes

  1. Change in depression score

    Time frame: 14 days

Secondary outcomes

  1. Change in BPRS+

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Naurex, Inc, an affiliate of Allergan plc

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2010
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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