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European Archives of Psychiatry and Clinical Neuroscience

Open Access 01-04-2024 | Sertraline | Original Paper

Lavender oil preparation Silexan is effective in mild-to-moderate major depression: a randomized, placebo- and reference-controlled trial

Authors: Siegfried Kasper, Hans-Peter Volz, Hans-Jürgen Möller, Sandra Schläfke, Stephan Klement, Ion-George Anghelescu, Erich Seifritz

Published in: European Archives of Psychiatry and Clinical Neuroscience

Abstract

Anxiety and depressive disorders have overlapping symptoms and share common neurobiological pathways. Antidepressant drugs have been demonstrated to be efficacious in anxiety as well. Vice versa, it may also be promising to investigate the efficacy of anxiolytic drugs such as silexan in major depressive disorder (MDD). Patients with a mild or moderate, single or recurrent episode of MDD and a total score of 19–34 points on the Montgomery Åsberg Depression Rating Scale (MADRS) were randomized to receive 1 × 80 mg/d silexan, 1 × 50 mg/d sertraline, or placebo double-blind, double-dummy for 56 days. The primary outcome measure was the MADRS total score change between baseline and treatment end. Treatment groups were compared using a treatment policy estimand. 498 subjects (silexan 170, sertraline 171, placebo 157) were treated and analyzed. After 8 weeks, silexan and sertraline were superior to placebo for MADRS total score reduction, with absolute differences to placebo of 2.17 (95% confidence interval: 0.58; 3.76) points and 2.59 (1.02; 4.17) points, respectively (p < 0.01). Moreover, silexan was superior to placebo for alleviation of functional impairment according to the Sheehan Disability Scale with a difference of 2.40 (1.04; 3.76) points (p < 0.001). Both treatments were well tolerated; eructation was the most frequent adverse effect of silexan. The study confirms the antidepressant efficacy of silexan in mild or moderate MDD, including significant improvements in the subjects’ functional capacity. The results for sertraline confirm the assay sensitivity of the trial. Both drugs were well tolerated.

Trial registration

EudraCT2020-000688–22 first entered on 12/08/2020.

Silexan® is the active substance of Lasea® (Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany).

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Title: Lavender oil preparation Silexan is effective in mild-to-moderate major depression: a randomized, placebo- and reference-controlled trial
Authors: Siegfried Kasper
Hans-Peter Volz
Hans-Jürgen Möller
Sandra Schläfke
Stephan Klement
Ion-George Anghelescu
Erich Seifritz
Publication date: 01-04-2024
Publisher: Springer Berlin Heidelberg
Keywords: Sertraline
Mood Disorders
Affective Disorder
Antidepressant Drugs
Antidepressant Drugs
Published in: European Archives of Psychiatry and Clinical Neuroscience
Print ISSN: 0940-1334
Electronic ISSN: 1433-8491
DOI: https://doi.org/10.1007/s00406-024-01783-2

At a glance: The STEP trials

Springer Medicine

Lavender oil preparation Silexan is effective in mild-to-moderate major depression: a randomized, placebo- and reference-controlled trial

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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