Effects of Silexan on the serotonin-1A receptor and microstructure of the human brain: a randomized, placebo-controlled, double-blind, cross-over study with molecular and structural neuroimaging

Int J Neuropsychopharmacol. 2014 Oct 31;18(4):pyu063. doi: 10.1093/ijnp/pyu063.

Abstract

Background: Recently, Silexan, a patented active substance comprised of an essential oil produced from Lavandula angustifolia flowers, has been authorized in Germany as a medicinal product for the treatment of states of restlessness related to anxious mood. Its efficacy has been shown in several forms of anxiety disorders. Findings from preclinical and clinical studies attribute a major role to the serotonin-1A receptor in the pathogenesis and treatment of anxiety.

Methods: To elucidate the effect of Silexan on serotonin-1A receptor binding, 17 healthy men underwent 2 positron emission tomography measurements using the radioligand [carbonyl-(11)C]WAY-100635 following the daily intake of 160 mg Silexan or placebo for a minimum of 8 weeks (randomized, double-blind, cross-over design). Additionally, structural magnetic resonance imaging and voxel-based morphometry analysis was performed to determine potential effects on gray matter microstructure.

Results: Serotonin-1A receptor binding potential was shown to be significantly reduced following the intake of Silexan compared with placebo in 2 large clusters encompassing the temporal gyrus, the fusiform gyrus and the hippocampus on one hand as well as the insula and anterior cingulate cortex on the other hand. No effects of Silexan on gray matter volume could be detected in this investigation.

Conclusion: This positron emission tomography study proposes an involvement of the serotonin-1A receptor in the anxiolytic effects of Silexan. The study was registered in the International Standard Randomized Controlled Trial Number Register as ISRCTN30885829 (http://www.controlled-trials.com/isrctn/).

Keywords: Silexan; gray matter volume; lavender oil; positron emission tomography; serotonin-1A receptor; structural magnetic resonance imaging.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Anxiety Agents / pharmacology*
  • Brain / anatomy & histology
  • Brain / diagnostic imaging
  • Brain / drug effects*
  • Brain / metabolism
  • Carbon Radioisotopes
  • Cross-Over Studies
  • Double-Blind Method
  • Gray Matter / anatomy & histology
  • Gray Matter / diagnostic imaging
  • Gray Matter / drug effects
  • Gray Matter / metabolism
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Oils, Volatile / pharmacology*
  • Piperazines
  • Plant Oils / pharmacology*
  • Positron-Emission Tomography
  • Pyridines
  • Radiopharmaceuticals
  • Receptor, Serotonin, 5-HT1A / metabolism*
  • Young Adult

Substances

  • Anti-Anxiety Agents
  • Carbon Radioisotopes
  • Oils, Volatile
  • Piperazines
  • Plant Oils
  • Pyridines
  • Radiopharmaceuticals
  • Receptor, Serotonin, 5-HT1A
  • N-(2-(4-(2-methoxyphenyl)-1-piperazinyl)ethyl)-N-(2-pyridinyl)cyclohexanecarboxamide
  • lavender oil

Associated data

  • ISRCTN/ISRCTN30885829