Summary:
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
Qualified Participants Must:
• •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.
Qualified Participants May Receive:
Free Meds, Free PE, Free labs, and compensation for time and travel