ANTIDEPRESSANT EFFECTS OF SILEXAN IN PATIENTS WITH PRIMARY ANXIETY SYNDROMES
Authors: Bartova *Lucie , Dold Markus , Volz Hans Peter , Seifritz Erich , Möller Hans-Jürgen , Kasper Siegfried 
Published: February 2025

Background

Anxiety and depressive diseases represent leading causes of burden worldwide with a globally increasing prevalence and suffering [1]. Although the heterogeneous clinical presentations do not always fully meet the criteria required for a diagnosis of a full-blown psychiatric disease as generalized anxiety disorder (GAD) and major depressive disorder (MDD), the so-called “subthreshold” or “subsyndromal” severity consistently showed a long-term negative impact on general health, life quality and functionality, and hence a decreased working capability in the affected individuals [2, 3]. For both, subsyndromal as well as full-blown manifestations, beneficial clinical effects on anxious, depressive, psychosomatic and cognitive symptoms and favorable safety profile lacking pharmacological interactions, undesirable sedation, withdrawal symptoms, or abuse potential were repeatedly confirmed for Silexan in patients with primary anxiety syndromes [4, 5]. Additionally, in-vitro studies indicated stimulation of synaptic plasticity, and in rats repeated administration of Silexan decreased immobility time in the forced swimming test [6].

Aims & Objectives

Based on the available clinical and preclinical international evidence, the pharmacological profile suggests that Silexan, a proprietary active substance produced from Lavandula angustifolia Miller flowers that has been approved in many countries for the oral treatment of anxiety disorders, may also have an antidepressant effect [6]. Hence, we conducted a meta-analysis based on data from placebo- controlled clinical trials with Silexan at a daily dose of 80 mg [7].

Methods

The present meta-analysis investigating comorbid depressive symptoms was conducted based on five randomized placebo-controlled clinical trials performed with Silexan in subthreshold anxiety (n = 3) and generalized anxiety disorders (n = 2) [7].

Results

The results of the item depressed mood assessed with the Hamilton Anxiety Rating Scale clearly showed that Silexan has a beneficial effect on co-occurring depressive symptoms in these patients [7]. A randomized, placebo-controlled clinical trial was performed in 315 patients suffering from mixed anxiety and depressive disorder [7]. Silexan was significantly superior to placebo regarding the antidepressant efficacy measured with the Montgomery Å sberg Depression Rating Scale as well as the anxiolytic efficacy measured with the Hamilton Anxiety Rating Scale [7].

Discussion & Conclusion

Based on these encouraging results and the need for an antidepressant agent with a beneficial efficacy and tolerability profile lacking unfavorable pharmacological interactions or withdrawal symptoms harming the quality of life, especially in patients with milder forms of depression [4, 7, 8], the antidepressant efficacy of Silexan is currently being investigated in an international randomized placebo-and reference-controlled phase III trial in patients with a mild to moderate major depressive episode (EudraCT Number: 2020-000688-22).

References

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2.Jacobson, K.B., et al., Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long- Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis, 2021. 73(3): p. e826-e829.3.

3.Peter, R.S., et al., Prevalence, determinants, and impact on general health and working capacity of post-acute sequelae of COVID-19 six to 12 months after infection: a population-based retrospective cohort study from southern Germany. medRxiv, 2022: p. 2022.03.14.22272316.4.

4.Dold, M., et al., Efficacy of Silexan in patients with anxiety disorders: a meta-analysis of randomized, placebo-controlled trials. Eur Arch Psychiatry Clin Neurosci, 2023. 273(7): p. 1615-1628.5.

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6.Kasper, S., et al., Silexan in anxiety disorders: Clinical data and pharmacological background. World J Biol Psychiatry, 2018. 19(6): p. 412-420.7.

7.Bartova, L., et al., Beneficial effects of Silexan on co-occurring depressive symptoms in patients with subthreshold anxiety and anxiety disorders: randomized, placebo-controlled trials revisited. Eur Arch Psychiatry Clin Neurosci, 2022.8.

8.Anxiety, depression, subthreshold, subsyndromal, lavender, Silexan, meta-analysis Seifritz, E., et al., Effect of anxiolytic drug silexan on sleep - a narrative review. World J Biol Psychiatry, 2022. 23(7): p. 493-500.