Effects of lavender oil preparation silexan on different symptoms of major depression - results from a randomized, controlled trial.
Major depressive disorder (MDD) is characterized by depressed mood, anhedonia, and loss of energy, which can be accompanied by associated symptoms and co-morbidities. Psychiatric scales such as the Montgomery Åsberg Depression Rating Scale (MADRS) must account for the complex nature of depression.
The MADRS total score change between baseline and week 8 was the primary outcome measure in a randomized, double-blind clinical trial investigating the antidepressant efficacy of 8 weeks' treatment with silexan compared to sertraline and placebo in patients with mild or moderate MDD. We report on a pre-planned, exploratory analysis of the individual MADRS items. Treatment effects were assessed using analyses of covariance with baseline adjustment, based on an estimand strategy.
498 subjects (silexan 170, sertraline 171, placebo 157) were treated and analyzed. After 8 weeks, silexan was superior to placebo for 5 out of the 9 MADRS items analyzed ('apparent sadness', 'reported sadness', 'reduced appetite', 'concentration difficulties', 'lassitude'; p<0.05) and showed clinically important adjusted mean value differences >0.2 points for 7 out of the 9 items. Item-level results for silexan and sertraline were mainly comparable.
Silexan had a strong over-all antidepressant effect, with the most pronounced improvements affecting the cardinal symptoms of depression.
EudraCT2020-000688-22 first entered on 12/08/2020.
The MADRS total score change between baseline and week 8 was the primary outcome measure in a randomized, double-blind clinical trial investigating the antidepressant efficacy of 8 weeks' treatment with silexan compared to sertraline and placebo in patients with mild or moderate MDD. We report on a pre-planned, exploratory analysis of the individual MADRS items. Treatment effects were assessed using analyses of covariance with baseline adjustment, based on an estimand strategy.
498 subjects (silexan 170, sertraline 171, placebo 157) were treated and analyzed. After 8 weeks, silexan was superior to placebo for 5 out of the 9 MADRS items analyzed ('apparent sadness', 'reported sadness', 'reduced appetite', 'concentration difficulties', 'lassitude'; p<0.05) and showed clinically important adjusted mean value differences >0.2 points for 7 out of the 9 items. Item-level results for silexan and sertraline were mainly comparable.
Silexan had a strong over-all antidepressant effect, with the most pronounced improvements affecting the cardinal symptoms of depression.
EudraCT2020-000688-22 first entered on 12/08/2020.
Authors
Hans-Jürgen Hans-Jürgen, Ion-George Ion-George, Hans-Peter Hans-Peter, Erich Erich, Sandra Sandra, Siegfried Siegfried
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