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:
• Be between 18 and 65 years of age
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Meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD)
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Have a current episode that has lasted more than 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
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Not be taking an 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
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Have a HDRS-17 score ≥ 18 at screening
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Have a HDRS-17 score ≥ 18 at pre-dose baseline
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Not be pregnant or plan to become pregnant during the course of the study
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If female use adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence), or be post menopausal / surgically sterile
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Have clinical laboratory values < 2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor
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Have the 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
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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 medication, physcial examination, labs and compensation.