Brain function Nervous System Diseases
Conditions
Interventions
1. The volunteers take 1 x 2 capsules orally in the morning for eight weeks followed by a wash out phase without treatment of 2-3 weeks followed by a second treatment period of eight weeks
2. The ran
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 20 - 50 years 2. Male 3. Caucasian 4. Informed consent 4. Healthy 5. Body mass index between 18 and 29.9 kg/m²
Exclusion criteria
Exclusion criteria: 1. Subjects with depression or comorbid axis I diagnoses 2. Subjects who are not naive to psychotropic drug treatment targeting the serotonergic system 3. Blood donation of approximately 500 ml within 3 months prior to the study start 4. A history of relevant diseases of vital organs, of the central nervous system or other organs 5. Subjects with a medical disorder, condition or history of such that would impair the subject?s ability to participate or complete this study 6. Febrile illness within 1 week before the start of the study 7. Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies 8. Regular daily consumption of more than ½ liter of regular beer or the equivalent quantity of approximately 20g of alcohol in another form 9. Regular daily consumption of more than 10 cigarettes 10. Regular use of therapeutic or recreational drugs 11. Subjects with known hypersensitivity to essential oils 12. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product; chemistry 13. Resting heart rate in the awake subject below 45 BPM or above 90 BPM 14. Systolic blood pressure below 100 mmHg or above 140 mmHg 15. Diastolic blood pressure above 85 mmHg 16. Subjects testing positive in the drug screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Regional 5-HT1A receptor binding potential of the brain after at least 8 weeks of Silexan (WS® 1265) treatment as compared to placebo (Positron emission tomography [PET] scan data) 2. Regional brain grey matter density and volume after at least 8 weeks of Silexan (WS®1265) treatment as compared to placebo (magnetic resonance imaging [MRI] scan data) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical Examination 2. Vital Signs 3. Adverse Events 4. Laboratory Tests | — |
Countries
Austria
Outcome results
None listed