Effects of Silexan on brain function and brain structure

ISRCTN ISRCTN30885829
DOI https://doi.org/10.1186/ISRCTN30885829
Secondary identifying numbers 750201.01.029
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

Study designSingle-centre randomized placebo-controlled double-blind cross-over study
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects 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 objectivesThe 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) studiedBrain function
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Silexan (WS® 1265)
Primary outcome measure1. 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 measures1. Physical examination
2. Vital signs
3. Adverse events
4. Laboratory tests
Overall study start date01/08/2011
Completion date31/12/2012

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants18
Key inclusion criteria1. 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 criteria1. 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 enrolment01/08/2011
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Austria

Study participating centre

Währinger Gürtel 18-20
Vienna
1090
Austria

Sponsor information

Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry

c/o Mr Stephan Klement
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Website http://www.schwabepharma.com/international/
ROR logo "ROR" https://ror.org/043rrkc78

Funders

Funder type

Industry

Willmar Schwabe GmbH and Co KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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