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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684163
• Other study ID #: GLYX13-C-202
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2012
• Last updated: February 18, 2016
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Naurex, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• GLYX-13 5 mg/kg
Intravenous administration of 5 mg/kg into arm.
• GLYX-13 10 mg/kg
Intravenous administration of 10 mg/kg into arm.
• Placebo
Intravenous administration of normal saline into arm.

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	PharmaSite Research , Inc.	Baltimore	Maryland
United States	University of Alabama Office of Psychiatric Clinical Research	Birmingham	Alabama
United States	Chicago Research Center	Chicago	Illinois
United States	University of Texas Southwestern Medical Center of Dallas	Dallas	Texas
United States	Pharmacology Research Institute	Encino	California
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Indiana University Health Neuroscience Center	Indianapolis	Indiana
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Pacific Institute of Medical Research	Los Angeles	California
United States	CRI Lifetree	Marlton	New Jersey
United States	Clinilabs, Inc.	New York	New York
United States	Michael R Liebowitz MD	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Evanston Premier Healthcare Research, LLC	Northbrook	Illinois
United States	CRI Lifetree	Phildadelphia	Pennsylvania
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	Global Medical Institutes LLC	Princeton	New Jersey
United States	Finger Lake Clinical Research	Rochester	New York
United States	Bostin Clinical Trials, Inc.	Roslindale	Massachusetts
United States	CRI Lifetree	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Summit Research Network	Seattle	Washington
United States	University of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale Score		6 weeks, 12 weeks, 16 weeks	No
Secondary	Clinical Global Impression of Change		6 weeks, 12 weeks, 16 weeks	No