Multi-centre, double-blind, placebo-controlled, randomised trial to prove the efficacy and safety of Silexan® (WS®1265) in patients with a major depressive episode of mild to moderate severity

Condition studied

Mild to moderate major depressive disorder

Investigational medicinal product(s)

Eligibility

Primary endpoint

The change in MADRS total score between Baseline and Week 8.

Endpoint detail

Efficacy endpoint: • Changes from Baseline in Clinical Global Impressions (CGI) (Item 1), Patient Health Questionnaire-9(PHQ-9) total score, Sheehan Disability Scale (SDS) total score at Week 8, Efficacy endpoint: • CGI (Item 2) at Week 8, Efficacy endpoint: • At least 50% reduction of MADRS total score between Baseline and Week 8 (responder), Efficacy endpoint: • MADRS total score < 10 at Week 8 (remitter)., Safety endpoint:• Frequency of participants with at least one Adverse Event (AE),Adverse Drug Reaction (ADR), serious AE; number, type, severity and seriousness of AEs, and their relationship to the Investigational Medicinal Product (IMP); frequency of participants with AEs leading to withdrawal, Safety endpoint:• Evaluation of safety assessments (physical examination, vital signs, 12-lead electrocardiography (ECG), laboratory evaluation, concomitant medication, non-medicinal psychiatric treatment), Safety endpoint:• Risk of suicide