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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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Depressive Disorder, Treatment-Resistant
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014