Anxiety disorder Mental and Behavioural Disorders Anxiety disorder
Conditions
Interventions
Cross-over with 3 sequences and 3 periods (part1: Silexan® WS® 1265 standard softgel capsule 80mg, 160mg , placebo
part2: Silexan® WS® 1265 enteric-coated capsule: 80mg, 160mg, placebo).
Each sequence for 14 days
one capsule once a day.
First administration at day 1 of each sequence before EEG sessions every hour until 4 hours after administation
then drugs are dispensed for the following 14 days.
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients aged 18 to 65 years (both inclusive) 2. Written informed consent in accordance with the legal requirement 3. Readiness and ability on the part of the patient to comply with the physician?s instructions and to fill in the self-assessment scales 4. Negative pregnancy test within 7 days before baseline visit in women with childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilisation or hysterectomy at least three months before the study starts) 5. Use of adequate double contraception in women with childbearing potential [oral or injectable contraception or hormonal intra-uterine system (IUS) combined with condom]
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial during the preceding 3 months 2. Pregnancy, lactation 3. Any acute medical disorder 4. History of relevant diseases of vital organs, of the central nervous system or other organs 5. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea) 6. Subjects with a medical disorder, condition or history of such that would impair the subject?s ability to participate or complete this study in the opinion of the investigator or the sponsor 7. Known hypersensitivity to lavender preparations 8. Regular daily consumption of more than 25 cigarettes 9. Regular daily consumption of more than half litre of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form 10. Regular daily consumption of more than one litre of xanthin-containing beverages 11. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product 12. Prohibited concomitant medication 13. Relevant deviation from the normal range in clinical chemistry, haematology or urinalysis 14. Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 100 BPM 15. Systolic blood pressure below 90 mmHg for women and below 100 mmHg for men or above 150 mmHg 16. Diastolic blood pressure above 95 mmHg 17. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within last 6 months before the study 18. Subjects testing positive in the drug screening 19. Participation in any previous clinical study with Silexan®/Lavender oil WS1265 or participation in a further clinical trial at the same time 20. Massive deviation from normal quantitativee electroencephalography (EEG) parameters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome variables describing the bio-availability of Silexan® to the brain 1. Quantitative source density EEG: electric power (V2) within the six frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) for each of the 17 electrode positions (102 variables). The variables are assessed for recording condition "eyes open" and "eyes closed" separately. Electrode positions from two different brain regions of interest (ROI) (fronto-temporal delta and theta power and centro-parietal alpha1,2 and beta1,2 power) are grouped and averaged together to give a total of six parameters (one for each frequency) for the recording condition of three challenges: performance of the d2-test, the concentration performance test CPT (under stress) and the memory test. Thus, 18 parameters will be assessed for the recordings during mental challenges. All parameters are assessed 1 - 4 hours after administration as difference to absolute power of pre-drug values (which are set to 100%). 2. Outcome variables of psychometry 2.1. Attention-Load-Test (d2-Test) 2.2. Concentration-Performance-Test (CPT) 2.3. Memory Test (ME) 3. Outcome variables of safety 3.1. Adverse events 3.2. Laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Germany
Outcome results
None listed