Efficacy of Silexan in anxious patients

INTERVENTION: 80 mg/day Silexan or placebo for 70 days CONDITION: Mixed anxiety and depressive disorder ; Mental and Behavioural Disorders ; Mixed anxiety and depressive disorder PRIMARY OUTCOME: The change of the HAMA total score and the MADRS total score SECONDARY OUTCOME: 1. Response criteria (50 % reduction; remission) based on the HAMA total score and on the MADRS total score; 2. Items 2 (tension) and 14 (behaviour at interview) of the HAMA, change and response; 3. Single items and subscores of the Hamilton Rating Scale for Anxiety; 4. Single items of the MADRS; 5. State‐Trait Anxiety Inventory (STAI); 6. Total score, subscores state anxiety and trait anxiety, early improvement on day 3; 7. Subscales of the Sheehan Disability Scale (SDS) and subscores of the SF‐36; 8. Clinical Global Impressions; 9. Hospital Anxiety and Depression Scale (HADS), total score change, subscore depression and subscore anxiety INCLUSION CRITERIA: 1. Diagnosis of mixed anxiety and depressive disorder (ICD‐10, F41.2) 2. Age 18 to 65 years 3. HAMA total score = 18 with item 1 ?anxious mood? = 2 (moderate) and item 6 ?depressed mood? = 2 (moderate) 4. BMI between 18 and 29.9 kg/m2 5. Written informed consent