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
Scientific
Währinger Gürtel 18-20
Vienna
1090
Austria
Study information
| Study design | Single-centre randomized placebo-controlled double-blind cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 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
1090
Austria
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
c/o Mr Stephan Klement
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com/international/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
