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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
NCT01234558
First received: November 3, 2010
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
 Drug: GLYX-13
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Naurex, Inc:

Primary Outcome Measures:
  • Change in depression score [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in BPRS+ [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234558

Locations
United States, Illinois
Mulitple
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Naurex, Inc
Investigators
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
  More Information

No publications provided

Responsible Party: Naurex, Inc
ClinicalTrials.gov Identifier: NCT01234558     History of Changes
Other Study ID Numbers: GLYX13-C201
Study First Received: November 3, 2010
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Naurex, Inc:
depression
NMDA antagonist
treatment resistant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013