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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
NCT01684163
First received: September 10, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Naurex, Inc:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale Score [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo injection
Normal saline
Drug: Placebo
Experimental: GLYX-13, 5 mg/kg
Low dose of GLYX-13
Drug: GLYX-13
Experimental: GLYX-13, 10 mg/kg
High dose of GLYX-13
Drug: GLYX-13

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects
  • Aged 18 to 65 years
  • Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD)
  • Current episode has lasted ≥ 8 weeks before Screening with an inadequate response (<50% reduction in the Antidepressant Treatment Response Questionnaire [ATRQ]) 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 from among the following: SSRI: SSRIs: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, paroxetine CR, sertraline; SNRIs: desvenlafaxine, duloxetine, venlafaxine, venlafaxine XR
  • HDRS-17 score ≥ 18 at screening.
  • HDRS-17 score ≥ 18 at 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 (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
  • 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, including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine, or 1 oz. of spirits consumed most weeks.
  • 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 including cocaine, marijuana, phencyclidine (PCP), ketamine (Special K), opioid, or other agent that the investigator feels is being abused
  • 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
  • Mass at screening visit of >120 kg
  • 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 including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684163

Locations
United States, Kansas
University of Kansas
Wichita, Kansas, United States, 67211
United States, New Jersey
CRI Lifetree
Marlton, New Jersey, United States, 08054
Global Medical Institutes LLC
Princeton, New Jersey, United States, 08540
United States, New York
Michael R Liebowitz MD
New York, New York, United States, 10128
United States, Pennsylvania
CRI Lifetree
Phildadelphia, Pennsylvania, United States, 19139
United States, Utah
CRI Lifetree
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Naurex, Inc
Investigators
Study Director: Lee Bastin, RN Ed.D. Naurex, Inc
  More Information

No publications provided

Responsible Party: Naurex, Inc
ClinicalTrials.gov Identifier: NCT01684163     History of Changes
Other Study ID Numbers: GLYX13-C-202
Study First Received: September 10, 2012
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Naurex, Inc:
depression
MDD
GLYX-13
HDRS-17
HAMD-17

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014