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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234558
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
Naurex, Inc

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: GLYX-13 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Normal Saline
IV placebo
Drug: GLYX-13
single IV dose
Other Name: ThrProProThr

Experimental: GLYX-13, 1 mg/kg Drug: GLYX-13
single IV dose
Other Name: ThrProProThr

Experimental: GLYX-13, 5 mg/kg Drug: GLYX-13
single IV dose
Other Name: ThrProProThr

Experimental: GLYX-13, 10 mg/kg Drug: GLYX-13
single IV dose
Other Name: ThrProProThr

Primary Outcome Measures :
  1. Change in depression score [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Change in BPRS+ [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01234558

United States, Illinois
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Naurex, Inc
Study Director: Ronald M Burch, MD, PhD Naurex, Inc
Principal Investigator: Vishaal Mehra, MD Artemis Clinical Research, San Diego CA
Principal Investigator: Raymond Manning, MD CNRI-LA, Pico Rivera CA
Principal Investigator: Paul Gross, MD Lehigh Center for Clinical Research, Allentown PA
Principal Investigator: Surinder Randhawa, MD Lynn Health Sciences Institute, Oklahoma City OK
Principal Investigator: David Greuner, MD CRI-WW, Philadelphia PA
Principal Investigator: David Krefetz, DO CRI-WW Lordes Hospital, Willingboro NJ
Principal Investigator: Benji Kurian, MD U Texas SW Medical Center, Dallas TX
Principal Investigator: Michael Lesem, MD Claghorn-Lesem Research Clinic, Houston TX
Principal Investigator: Matthew Macaluso, MD Clinical Research Center, Univ Kansas, Wichita KS
Principal Investigator: Stephen Murray, MD PhD Clinilabs, New York, NY

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Naurex, Inc Identifier: NCT01234558     History of Changes
Other Study ID Numbers: GLYX13-C201
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by Naurex, Inc:
NMDA antagonist
treatment resistant

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms