An oral lavender oil preparation produced broad antidepressant effects in patients with mild-to-moderate major depressive disorder (MDD), with a symptom profile similar to that of the SSRI sertraline.
Results of a randomized controlled trial involving nearly 500 patients showed that the preparation, known as Silexan, was significantly more effective than placebo after 8 weeks for five of nine symptoms assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS), including apparent and reported sadness, reduced appetite, concentration difficulties, and lassitude.
The findings point to an “independent, direct antidepressant effect,” the investigators led by Hans-Jürgen Möller, MD, Ludwig Maximillian University, Munich, Germany, noted.
The findings were published in the September issue of the International Journal of Neuropsychopharmacology.
From Anxiety to Depression
Silexan is a standardized oral essential oil derived from Lavandula angustifolia and is registered as a medicinal product for anxiety disorders. In previous randomized, placebo-controlled trials, it not only reduced anxiety symptoms but also improved co-morbid depression.
An antidepressant effect was also observed in patients with mixed anxiety and depressive disorder, raising the possibility that its benefits extend beyond anxiolysis.
The researchers point out that MDD is highly heterogeneous: Patients present with different constellations of symptoms. To characterize the antidepressant effects of Silexan, they looked beyond the overall MADRS score and examined changes in individual items.
In addition, to better understand which depressive symptoms were driving overall benefit, the investigators conducted a preplanned exploratory analysis of individual MADRS items.
In the previously reported double-blind, double-dummy LEAD trial, Silexan 80 mg/d and sertraline 50 mg/d were both more effective than placebo after 8 weeks in terms of total MADRS total score in patients with mild-to-moderate MDD.
In the current preplanned exploratory analysis of the same trial, the investigators examined whether those overall improvements were reflected across individual depressive symptoms.
The analysis included 498 predominantly White adults from sites in Germany and Poland with mild or moderate, single or recurrent MDD. Participants were randomly assigned to 8 weeks of Silexan, sertraline, or placebo. Nine individual MADRS items were assessed.
Core MDD Symptoms Improve
Participants were randomly assigned to receive Silexan (n = 170; mean age, 45.8 years; 69.4% women), sertraline (n = 171; mean age, 44.7 years; 64.3% women), or placebo (n = 157; mean age, 46.6 years; 63.1% women) for 8 weeks.
Results showed that both Silexan and sertraline were superior to placebo in reducing MADRS total scores (P = .008 and P = .001, respectively).
Additionally, Silexan was significantly superior to placebo on five MADRS items: apparent sadness (P = .014), reported sadness (P = .011), reduced appetite (P = .048), concentration difficulties (P = .011), and lassitude (P = .003).
Silexan also showed adjusted mean differences of more than 0.2 point vs placebo for inner tension and inability to feel, although both narrowly missed statistical significance (P = .051 and P = .058, respectively). Overall, item-level outcomes with Silexan and sertraline were largely comparable.
The most pronounced improvements with Silexan were observed in symptoms central to MDD, including depressed mood, anhedonia, and loss of energy.
However, the researchers noted that the item-level analyses were exploratory and not adjusted for multiple comparisons.
The researchers emphasized that the LEAD study was also not “intended nor powered” to demonstrate superiority at the individual-item level, and no validated threshold exists for determining a clinically meaningful between-group difference for individual MADRS items.
Even so, the investigators said the analysis provides additional insight into how Silexan may affect specific symptoms of MDD.
The study was funded by the manufacturer of Silexan. Disclosure information for the study investigators is available in the original study publication.
https://www.medscape.com/viewarticle/lavender-oil-cuts-core-symptoms-major-depression-2026a10010v3
