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

Sponsor

Naurex, Inc, an affiliate of Allergan plc (Industry)

Overall Status

Completed

CT.gov ID

NCT01684163

Collaborator

(none)

369

Enrollment

Locations

Arms

Duration (Months)

14.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: GLYX-13 5 mg/kg Drug: GLYX-13 10 mg/kg Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

369 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo injection

Normal saline

Drug: Placebo

Intravenous administration of normal saline into arm.

Other Names:

Normal Saline

Experimental: GLYX-13, 5 mg/kg

Low dose of GLYX-13

Drug: GLYX-13 5 mg/kg

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

Drug: GLYX-13 10 mg/kg

Intravenous administration of 10 mg/kg into arm.

Other Names:

GLYX-13 IV Dose

Outcome Measures

Primary Outcome Measures

Change in Hamilton Depression Rating Scale Score [6 weeks, 12 weeks, 16 weeks]

Secondary Outcome Measures

Clinical Global Impression of Change [6 weeks, 12 weeks, 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Office of Psychiatric Clinical Research	Birmingham	Alabama	United States	35294
2	Pharmacology Research Institute	Encino	California	United States	91316
3	Pharmacology Research Institute	Los Alamitos	California	United States	90720
4	Pacific Institute of Medical Research	Los Angeles	California	United States	90024
5	Pharmacology Research Institute	Newport Beach	California	United States	92660
6	Artemis Institute for Clinical Research	San Diego	California	United States	92103
7	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
8	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30308
9	Atlanta Institute of Medicine and Research	Atlanta	Georgia	United States	30328
10	Chicago Research Center	Chicago	Illinois	United States	60634
11	Evanston Premier Healthcare Research, LLC	Northbrook	Illinois	United States	60201
12	Indiana University Health Neuroscience Center	Indianapolis	Indiana	United States	46201
13	University of Kansas	Wichita	Kansas	United States	67211
14	PharmaSite Research , Inc.	Baltimore	Maryland	United States	21208
15	Bostin Clinical Trials, Inc.	Roslindale	Massachusetts	United States	02131
16	CRI Lifetree	Marlton	New Jersey	United States	08054
17	Global Medical Institutes LLC	Princeton	New Jersey	United States	08540
18	Clinilabs, Inc.	New York	New York	United States	10019
19	Michael R Liebowitz MD	New York	New York	United States	10128
20	Finger Lake Clinical Research	Rochester	New York	United States	14618
21	Summit Research Network (Oregon), Inc.	Portland	Oregon	United States	97210
22	Lehigh Center for Clinical Research	Allentown	Pennsylvania	United States	18104
23	CRI Lifetree	Phildadelphia	Pennsylvania	United States	19139
24	University of Texas Southwestern Medical Center of Dallas	Dallas	Texas	United States	75235
25	CRI Lifetree	Salt Lake City	Utah	United States	84106
26	Summit Research Network	Seattle	Washington	United States	98104