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The treatment phase was followed by a 1 wk down-titration phase introduced for the withdrawal of paroxetine, and to document possible discontinuation effects. All patients provided written informed consent.
The principles of good clinical practice and the Declaration of Helsinki were adhered to.
Participants The study participants were male and female out-patients who were treated in 57 psychiatric and general practices in Germany. Other psychotropic medication and psychotherapy were not allowed during study participation, and psychotropic agents were also excluded during a 30 d period before the baseline visit.
Interventions, blinding Silexan is a defined preparation from Lavandula angustifolia derived from the fresh flowering tops of the plant by steam distillation.
Batch to batch consistency is assured by well defined, highly standardized processes of cultivation, harvesting, and distillation. In this trial the product was available in immediate release soft gelatine capsules containing 80 or 160 mg of lavender oil.Apparently I hide the drool well.
Paroxetine was supplied in capsules containing 20 mg. For each drug an identically matched placebo was available.
The study participants were instructed to swallow the capsules unchewed. During down-titration all participants had to take the study medication every second day.
In patients randomized to Silexan all capsules taken during down-titration contained placebo. Outcomes Efficacy and safety assessments were performed at baseline and at the end of weeks 2, 6, and 10.
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