Efficacy of Silexan in Patients with a Major Depressive Episode – First Results from a Multi-centre, Double-blind, Randomised, Placebo- and Reference-controlled Phase III Trial
| Autor: | S. Kasper, E. Seifritz, H.-P. Volz |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2024 |
| Předmět: | |
| Zdroj: | European Psychiatry, Vol 67, Pp S224-S225 (2024) |
| Druh dokumentu: | article |
| ISSN: | 0924-9338 1778-3585 |
| DOI: | 10.1192/j.eurpsy.2024.479 |
| Popis: | Introduction Silexan [1], an essential oil from Lavandula angustifolia flowers, is the active substance of a medicinal product for oral use in the treatment of anxiety disorders. It has been shown to be effective in the treatment of patients suffering from mixed anxiety and depression. [1] Silexan® is a special essential oil from Lavandula angustifolia, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany Objectives The trial (ISRCTN36202964) was conducted to investigate the antidepressant efficacy of Silexan in patients with a major depressive episode compared to placebo and Sertraline. Methods Adult patients (≥18 years) suffering from a major depressive episode of mild to moderate severity according to ICD‑10 were included. Further inclusion criterion was a total score of 19 – 34 points in the Montgomery-Asberg-Depression Rating Scale (MADRS). Randomised patients took 80 mg Silexan, 50 mg Sertraline, or placebo once daily over 8 weeks. Primary efficacy endpoint was the change of the MADRS total score between baseline and week 8. Response (a reduction of the MADRS total score ≥50%), remission (MADRS total score |
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