Trial record 1 of 1 for:    GLYX13-C-202
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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

September 10, 2012
February 18, 2014
October 2012
March 2014   (final data collection date for primary outcome measure)
Change in Hamilton Depression Rating Scale Score [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01684163 on ClinicalTrials.gov Archive Site
Clinical Global Impression of Change [ Time Frame: 6 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: GLYX-13
  • Drug: Placebo
  • Placebo Comparator: Placebo injection
    Normal saline
    Intervention: Drug: Placebo
  • Experimental: GLYX-13, 5 mg/kg
    Low dose of GLYX-13
    Intervention: Drug: GLYX-13
  • Experimental: GLYX-13, 10 mg/kg
    High dose of GLYX-13
    Intervention: Drug: GLYX-13
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
June 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01684163
GLYX13-C-202
No
Naurex, Inc
Naurex, Inc
Not Provided
Study Director: Lee Bastin, RN Ed.D. Naurex, Inc
Naurex, Inc
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP