| Study name |
Phase 2, double‐blind, placebo controlled, randomized withdrawal, parallel efficacy and safety study of GLYX‐13 in participants with inadequate/partial response to antidepressants during the current episode of major depressive disorder |
| Methods |
GLYX‐13 is a NMDA receptor glycine site partial agonist being studied in participants 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 |
| Participants |
Male and female participants. 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 HRSD‐17 score ≥ 18 at screening. HRSD‐17 score ≥ 18 at predose baseline. Female participants 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 (e.g. oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female participants may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post‐menopausal |
| Interventions |
Experimental Arm 1: GLYX‐13, 5 mg/kg Experimental Arm 2: GLYX‐13, 10 mg/kg Comparator Arm 3: placebo saline injection |
| Outcomes |
Primary Outcome Measures: Change in HRSD score. Secondary Outcome Measures: Clinical Global Impression of Change |
| Starting date |
October 2012 |
| Contact information |
Lee Bastin, RN Ed.D., Naurex, Inc |
| Notes |
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