title: Efficacy of Silexan in mixed anxiety-depression--A randomized, placebo-controlled trial.
abstract: Mixed anxiety and depressive disorder (MADD; ICD-10 F41.2) is a condition characterized by subsyndromal symptoms of anxiety and depression, neither of which are clearly predominant. Silexan has been demonstrated to be efficacious in subsyndromal and syndromal anxiety disorders and co-morbid depressive symptoms. In this study 318 adult out-patients with MADD according to ICD-10 criteria, a total score ≥18 points on the Hamilton Anxiety Rating Scale (HAMA), and at least moderately severe anxious and depressed mood were randomized and received 1×80mg Silexan or placebo in double-blind fashion for a scheduled period of 70 days. Primary outcome measures were the HAMA and Montgomery Åsberg Depression Rating Scale (MADRS) total score changes between baseline and treatment end. The HAMA total score decreased by 10.8±9.6 points for Silexan and by 8.4±8.9 points for placebo (treatment group difference: p<0.01, one-sided; ANCOVA with factors for treatment and centre and the baseline value as covariate), and total score decreases of 9.2±9.9 and 6.1±7.6 points, respectively, were observed for the MADRS (p<0.001). Compared to placebo, the patients treated with Silexan had a better over-all clinical outcome and showed more pronounced improvements of impaired daily living skills and health related quality of life. Eructation was the only adverse event with a substantially higher incidence under Silexan. The study thus demonstrates that Silexan is efficacious and safe in the treatment of MADD.
authors.affiliation: Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. Electronic address: sci-biolpsy@meduniwien.ac.at.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Kasper
authors.affiliation: Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Volz
authors.affiliation: Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
authors.forename: Angelika
authors.initials: A
authors.lastname: Dienel
authors.affiliation: Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Schläfke
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000150:complications* / Q000188:drug therapy*; D003863:Depression / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D027523:Lavandula; D008297:Male; D008875:Middle Aged; D009822:Oils, Volatile / Q000627:therapeutic use*; D010938:Plant Oils / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D009822:Oils, Volatile; D010938:Plant Oils; C045718:lavender oil
keywords: Anxiety; Clinical trial; Depression; Lavender; Silexan; Treatment efficacy