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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234558
First Posted: November 4, 2010
Last Update Posted: September 12, 2012
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.
Information provided by (Responsible Party):
Naurex, Inc
November 3, 2010
November 4, 2010
September 12, 2012
May 2011
June 2012   (Final data collection date for primary outcome measure)
Change in depression score [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT01234558 on ClinicalTrials.gov Archive Site
Change in BPRS+ [ Time Frame: 14 days ]
Same as current
Not Provided
Not Provided
 
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
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: GLYX-13
single IV dose
Other Name: ThrProProThr
  • Placebo Comparator: Normal Saline
    IV placebo
    Intervention: Drug: GLYX-13
  • Experimental: GLYX-13, 1 mg/kg
    Intervention: Drug: GLYX-13
  • Experimental: GLYX-13, 5 mg/kg
    Intervention: Drug: GLYX-13
  • Experimental: GLYX-13, 10 mg/kg
    Intervention: Drug: GLYX-13
Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
July 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01234558
GLYX13-C201
No
Not Provided
Not Provided
Naurex, Inc
Naurex, Inc
Not Provided
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
Naurex, Inc
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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