Clinical trial NCT01684163: Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
MDD
GLYX-13
HDRS-17
HAMD-17
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2012-09-12
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale Score
timeFrame: 6 weeks, 12 weeks, 16 weeks
Secondary outcomes:
measure: Clinical Global Impression of Change
timeFrame: 6 weeks, 12 weeks, 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Office of Psychiatric Clinical Research
state: Alabama
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: Pacific Institute of Medical Research
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Northbrook
country: United States
facility: Evanston Premier Healthcare Research, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Neuroscience Center
state: Indiana
city: Wichita
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: PharmaSite Research , Inc.
state: Maryland
city: Roslindale
country: United States
facility: Bostin Clinical Trials, Inc.
state: Massachusetts
city: Marlton
country: United States
facility: CRI Lifetree
state: New Jersey
city: Princeton
country: United States
facility: Global Medical Institutes LLC
state: New Jersey
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
city: New York
country: United States
facility: Michael R Liebowitz MD
state: New York
city: Rochester
country: United States
facility: Finger Lake Clinical Research
state: New York
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Phildadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center of Dallas
state: Texas
city: Salt Lake City
country: United States
facility: CRI Lifetree
state: Utah
city: Seattle
country: United States
facility: Summit Research Network
state: Washington
Study officials:
affiliation: Naurex Inc, an affilate of Allergan plc
name: Medical Director
role: STUDY_DIRECTOR
References: