Effects of Silexan on brain function and brain structure

ISRCTN	ISRCTN30885829
DOI	https://doi.org/10.1186/ISRCTN30885829
Protocol serial number	750201.01.029
Sponsor	Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder	Willmar Schwabe GmbH and Co KG (Germany)

Submission date: 12/07/2011
Registration date: 04/08/2011
Last edited: 25/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Siegfried Kasper
Scientific

Währinger Gürtel 18-20
Vienna
1090
Austria

Study information

Primary study design	Interventional
Study design	Single-centre randomized placebo-controlled double-blind cross-over study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	Effects of Silexan (WS® 1265) on the serotonin-1A (5-HT1A) receptor and microstructure of the brain: a randomized, placebo-controlled, double-blind, cross-over study with molecular and structural neuroimaging
Study objectives	The objective of the study is to detect effects of an at least eight-week treatment with Silexan(WS® 1265) on the serotonergic system and the microstructure of the brain via molecular and structural neuroimaging.
Ethics approval(s)	Ethics Committee of the Medical University of Vienna (Ethik-Kommission des Medizinischen Universität Wien), 11/07/2011, ref: 475/2011
Health condition(s) or problem(s) studied	Brain function
Intervention	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 randomized order of the two eight-weeks-periods is Silexan - placebo or placebo - Silexan 3. The dosage of a capsule with Silexan is 80 mg
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Silexan (WS® 1265)
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Physical examination 2. Vital signs 3. Adverse events 4. Laboratory tests
Completion date	31/12/2012

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	18
Key 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
Key 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
Date of first enrolment	01/08/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Austria

Study participating centre

Währinger Gürtel 18-20

Vienna
1090
Austria

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	31/10/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes