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

Conditions

Mild to moderate major depressive disorder

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGPlacebo to Silexan 80 mg

DRUGSilexan 80 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in MADRS total score between Baseline and Week 8.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Austria, Germany

Outcome results

None listed