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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.
 
ClinicalTrials.gov Identifier: NCT01234558
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Study Description
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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 Design
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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


Arms and Interventions
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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


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

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

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01234558


Locations
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United States, Illinois
Mulitple
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Ronald M Burch, MD, PhD Naurex, Inc, an affiliate of Allergan plc
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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT01234558    
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, an affiliate of Allergan plc:
depression
NMDA antagonist
treatment resistant
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms