Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.029
Study information
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
Acronym
Study hypothesis
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
Ethics Committee of the Medical University of Vienna (Ethik-Kommission des Medizinischen Universität Wien), 11/07/2011, ref: 475/2011
Study design
Single-centre randomized placebo-controlled double-blind cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Silexan (WS® 1265)
Primary outcome measure
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 outcome measures
1. Physical examination
2. Vital signs
3. Adverse events
4. Laboratory tests
Overall trial start date
01/08/2011
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
18
Participant 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
Recruitment start date
01/08/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Austria
Trial participating centre
Währinger Gürtel 18-20
Vienna
1090
Austria
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
c/o Mr Stephan Klement
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Willmar Schwabe GmbH and Co KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25522403