Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants

February 18, 2016 updated by: Naurex, Inc, an affiliate of Allergan plc

Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder

GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major depressive disorder (depression) who have responded inadequately to another antidepressant drug during the current episode. This trial will assess the effects of GLYX-13 on depression when added to another antidepressant drug that the patient is already taking.

Study Overview

Detailed Description

To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal period).

Study Type

Interventional

Enrollment (Actual)

369

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

    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Office of Psychiatric Clinical Research
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90024
        • Pacific Institute of Medical Research
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Florida
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine and Research
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center
      • Northbrook, Illinois, United States, 60201
        • Evanston Premier Healthcare Research, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46201
        • Indiana University Health Neuroscience Center
    • Kansas
      • Wichita, Kansas, United States, 67211
        • University of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • PharmaSite Research , Inc.
    • Massachusetts
      • Roslindale, Massachusetts, United States, 02131
        • Bostin Clinical Trials, Inc.
    • New Jersey
      • Marlton, New Jersey, United States, 08054
        • CRI Lifetree
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes LLC
    • New York
      • New York, New York, United States, 10019
        • Clinilabs, Inc.
      • New York, New York, United States, 10128
        • Michael R Liebowitz MD
      • Rochester, New York, United States, 14618
        • Finger Lake Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon), Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
      • Phildadelphia, Pennsylvania, United States, 19139
        • CRI Lifetree
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center of Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • CRI Lifetree
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects
  • Aged 18 to 65 years
  • Meets DSM-IV-TR) criteria for major depressive disorder (MDD)
  • Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and duration for the current episode
  • Taking no antidepressant agent currently or taking an SSRI or SNRI
  • HDRS-17 score ≥ 18 at screening and predose baseline
  • Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control and who do not plan to become pregnant during the course of the study.
  • Clinical laboratory values < 2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor
  • Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
  • Based on the investigator and Naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to major depressive episodes (MDEs) are permitted.

Exclusion Criteria:

  • Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (ADHD), or PTSD
  • A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
  • Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis
  • Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes
  • Currently hospitalized or residing in an in-patient facility during the study participation
  • Substance abuse within the last 12 months
  • Women who are planning to become pregnant during the course of the study
  • Allergy or intolerance to current antidepressant or other current medications
  • Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial with the exception of GLYX13-C-201.
  • Positive screen for drugs of abuse
  • Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or vagal nerve stimulation (VNS) for the current depressive episode
  • Pose current (past 6 months) suicide risk based on administration of the C SSRS and the investigator's clinical judgment
  • Human immunodeficiency virus (HIV) infection (based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease
  • Females who are currently pregnant or planning to become pregnant during the course of the study
  • Dextromethorphan or tramadol since these are serotonin uptake inhibitors
  • History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor [NMDAR] ligands

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo injection
Normal saline
Intravenous administration of normal saline into arm.
Other Names:
  • Normal Saline
Experimental: GLYX-13, 5 mg/kg
Low dose of GLYX-13
Intravenous administration of 5 mg/kg into arm.
Other Names:
  • GLYX-13 IV Dose
Experimental: GLYX-13, 10 mg/kg
High dose of GLYX-13
Intravenous administration of 10 mg/kg into arm.
Other Names:
  • GLYX-13 IV Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hamilton Depression Rating Scale Score
Time Frame: 6 weeks, 12 weeks, 16 weeks
6 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression of Change
Time Frame: 6 weeks, 12 weeks, 16 weeks
6 weeks, 12 weeks, 16 weeks

Collaborators and Investigators

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

Investigators

  • Study Director: Medical Director, Naurex Inc, an affilate of Allergan plc

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

November 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

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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