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

September 10, 2012 updated by: Naurex, Inc, an affiliate of Allergan plc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Mulitple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
IV placebo
Drug: GLYX-13
single IV dose
Other Names:
  • ThrProProThr
Experimental: GLYX-13, 1 mg/kg
Drug: GLYX-13
single IV dose
Other Names:
  • ThrProProThr
Experimental: GLYX-13, 5 mg/kg
Drug: GLYX-13
single IV dose
Other Names:
  • ThrProProThr
Experimental: GLYX-13, 10 mg/kg
Drug: GLYX-13
single IV dose
Other Names:
  • ThrProProThr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression score
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in BPRS+
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naurex, Inc, an affiliate of Allergan plc

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLYX13-C201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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