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

doi:10.1007/s00406-024-01783-2

. 2024 Apr 1.

doi: 10.1007/s00406-024-01783-2. Online ahead of print.

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

Siegfried Kasper¹, Hans-Peter Volz², Hans-Jürgen Möller³, Sandra Schläfke⁴, Stephan Klement⁴, Ion-George Anghelescu⁵, Erich Seifritz⁶

Affiliations

¹ Center for Brain Research, Medical University of Vienna, Spitalgasse 4, 1090, Vienna, Austria. siegfried.kasper@meduniwien.ac.at.
² Würzburg, Former Medical Director Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
³ Clinic and Policlinic for Psychiatry and Psychotherapy, Ludwig Maximilian University, Munich, Germany.
⁴ Department of Research and Development, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
⁵ Clinic of Psychiatry and Psychotherapy, Mental Health Institute Berlin, Berlin, Germany.
⁶ Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland.

PMID: 38558147
DOI: 10.1007/s00406-024-01783-2

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

Siegfried Kasper et al. Eur Arch Psychiatry Clin Neurosci. 2024.

. 2024 Apr 1.

doi: 10.1007/s00406-024-01783-2. Online ahead of print.

Authors

Siegfried Kasper¹, Hans-Peter Volz², Hans-Jürgen Möller³, Sandra Schläfke⁴, Stephan Klement⁴, Ion-George Anghelescu⁵, Erich Seifritz⁶

Affiliations

¹ Center for Brain Research, Medical University of Vienna, Spitalgasse 4, 1090, Vienna, Austria. siegfried.kasper@meduniwien.ac.at.
² Würzburg, Former Medical Director Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
³ Clinic and Policlinic for Psychiatry and Psychotherapy, Ludwig Maximilian University, Munich, Germany.
⁴ Department of Research and Development, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
⁵ Clinic of Psychiatry and Psychotherapy, Mental Health Institute Berlin, Berlin, Germany.
⁶ Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland.

PMID: 38558147
DOI: 10.1007/s00406-024-01783-2

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 registrationEudraCT2020-000688-22 first entered on 12/08/2020.

Keywords: Clinical trial; Depression; Lavender; Silexan; Treatment efficacy.

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References

1. Kasper S, Gastpar M, Müller WE, Volz HP, Möller HJ, Dienel A, Schläfke S (2010) Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of “subsyndromal” anxiety disorder: a randomized, double-blind, placebo controlled trial. Int Clin Psychopharmacol 25(6):277–287. https://doi.org/10.1097/YIC.0b013e32833b3242 - DOI - PubMed
1. Woelk H, Schläfke S (2010) A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine 17(2):94–99 - DOI - PubMed
1. Kasper S, Gastpar M, Müller WE, Volz H-P, Möller H-J, Schläfke S, Dienel A (2014) Lavender oil preparation Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol 17(6):859–869. https://doi.org/10.1017/S1461145714000017 - DOI - PubMed
1. Kasper S, Möller HJ, Volz HP, Schläfke S, Dienel A (2017) Silexan in generalized anxiety disorder: investigation of the therapeutic dosage range in a pooled data set. Int Clin Psychopharmacol 32(4):195–204. https://doi.org/10.1097/YIC.0000000000000176 - DOI - PubMed
1. Möller HJ, Volz HP, Dienel A, Schläfke S, Kasper S (2019) Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials. Eur Arch Psychiatry Clin Neurosci 269(2):183–193. https://doi.org/10.1007/s00406-017-0852-4 - DOI - PubMed

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[1] Kasper S, Gastpar M, Müller WE, Volz HP, Möller HJ, Dienel A, Schläfke S (2010) Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of “subsyndromal” anxiety disorder: a randomized, double-blind, placebo controlled trial. Int Clin Psychopharmacol 25(6):277–287. https://doi.org/10.1097/YIC.0b013e32833b3242 - DOI - PubMed

[2] Kasper S, Gastpar M, Müller WE, Volz HP, Möller HJ, Dienel A, Schläfke S (2010) Silexan, an orally administered Lavandula oil preparation, is effective in the treatment of “subsyndromal” anxiety disorder: a randomized, double-blind, placebo controlled trial. Int Clin Psychopharmacol 25(6):277–287. https://doi.org/10.1097/YIC.0b013e32833b3242 - DOI - PubMed

[3] Woelk H, Schläfke S (2010) A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine 17(2):94–99 - DOI - PubMed

[4] Woelk H, Schläfke S (2010) A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine 17(2):94–99 - DOI - PubMed

[5] Kasper S, Gastpar M, Müller WE, Volz H-P, Möller H-J, Schläfke S, Dienel A (2014) Lavender oil preparation Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol 17(6):859–869. https://doi.org/10.1017/S1461145714000017 - DOI - PubMed

[6] Kasper S, Gastpar M, Müller WE, Volz H-P, Möller H-J, Schläfke S, Dienel A (2014) Lavender oil preparation Silexan is effective in generalized anxiety disorder – a randomized, double-blind comparison to placebo and paroxetine. Int J Neuropsychopharmacol 17(6):859–869. https://doi.org/10.1017/S1461145714000017 - DOI - PubMed

[7] Kasper S, Möller HJ, Volz HP, Schläfke S, Dienel A (2017) Silexan in generalized anxiety disorder: investigation of the therapeutic dosage range in a pooled data set. Int Clin Psychopharmacol 32(4):195–204. https://doi.org/10.1097/YIC.0000000000000176 - DOI - PubMed

[8] Kasper S, Möller HJ, Volz HP, Schläfke S, Dienel A (2017) Silexan in generalized anxiety disorder: investigation of the therapeutic dosage range in a pooled data set. Int Clin Psychopharmacol 32(4):195–204. https://doi.org/10.1097/YIC.0000000000000176 - DOI - PubMed

[9] Möller HJ, Volz HP, Dienel A, Schläfke S, Kasper S (2019) Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials. Eur Arch Psychiatry Clin Neurosci 269(2):183–193. https://doi.org/10.1007/s00406-017-0852-4 - DOI - PubMed

[10] Möller HJ, Volz HP, Dienel A, Schläfke S, Kasper S (2019) Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials. Eur Arch Psychiatry Clin Neurosci 269(2):183–193. https://doi.org/10.1007/s00406-017-0852-4 - DOI - PubMed

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

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

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