Depressive Disorder, Major Clinical Trial
Official title:
A Six-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of GSK561679 Compared to Placebo in Female Subjects, Diagnosed With Major Depressive Disorder
This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder
This is a double-blind placebo controlled study to assess the CRF1 receptor antagonist,
GSK561679, for treatment of depression in adult females diagnosed with Major Depressive
Disorder (MDD). A treatment regimen of 350mg/day will be utilized to assess both efficacy and
tolerability. Subjects will be randomized in equal numbers (n=75/arm) to the treatment arm
and the placebo arm for a 6-week treatment period.
Efficacy will be assessed by determining the change from baseline in symptoms of MDD and
anxiety utilizing the Bech Melancholia scale (Bech), Hamilton Rating Scale for Depression
(HamD17), Inventory of Depressive Symptomatology-Self-Report (IDS-SR), Clinical Global
Impression - Severity of Illness (CGI-S), Clinical Global Impression - Global Improvement
(CGI-I), Medical Outcomes Study 12-item Sleep Module (MOS 12), Cohen Perceived Stress Test
(PSS), Hamilton Anxiety Scale (HamA), and Dexamethasone Suppression Test (DST). Safety and
tolerability will be assessed by determining the incidence of adverse events (AEs), vital
signs, BMI, weight, clinical laboratory parameters, including ECGs, during the treatment and
pre & post-treatment phases, and Discontinuation Emergent Signs and Symptoms (DESS). In
addition, the incidence of suicidality will be assessed by the Columbia Suicide Severity
Rating Scale (C-SSRS).
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