Condition category
Nervous System Diseases
Date applied
12/07/2011
Date assigned
04/08/2011
Last edited
25/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Siegfried Kasper

ORCID ID

Contact details

Währinger Gürtel 18-20
Vienna
1090
Austria

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 measures

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

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

http://www.schwabepharma.com/international/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25522403

Publication citations

Additional files

Editorial Notes