Phase III study to prove the efficacy, safety and tolerability of Silexan® in patients with anxiety disorder

ISRCTN	ISRCTN13032035
DOI	https://doi.org/10.1186/ISRCTN13032035
Protocol serial number	750201.01.013
Sponsor	Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder	Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Submission date: 04/08/2008
Registration date: 12/09/2008
Last edited: 12/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angelika Dienel
Scientific

Willmra-Schwabe-Strasse 4
Karlsruhe
76227
Germany

Study information

Primary study design	Interventional
Study design	Phase III, multi-centre, double-blind, randomised, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To prove the efficacy of Silexan® (a lavender oil preparation) in patients suffering from an anxiety disorder not otherwise specified (NOS).
Ethics approval(s)	Ethics Committee of the State Medical Chamber of Baden-Württemberg (Landesärztekammer Baden-Württemberg). Date of approval: 15/06/2004 (ref: 093-04)
Health condition(s) or problem(s) studied	Anxiety disorder not otherwise specified
Intervention	Silexan® 80 mg (1 capsule) per day or placebo orally for 10 weeks.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Silexan®
Primary outcome measure(s)	1. Change in HAMA total score, assessed every 2 weeks for 10 weeks 2. Change in PSQI total score, assessed at baseline and Week 2, 6 and 10
Key secondary outcome measure(s)	1. Subscores of HAMA, assessed every 2 weeks for 10 weeks 2. Subscores of PSQI, assessed at baseline and Week 2, 6 and 10 3. Clinical Global Impressions (CGI) scale at baseline, Week 8 and 10 4. Zung's Self-rating Anxiety Scale, assessed every 2 weeks for 10 weeks 5. Short-Form 36 (SF-36) Health Survey Questionnaire at baseline and Week 10 6. Safety, assessed every 2 weeks for 10 weeks. After this period, adverse events were monitored until they had subsided or had stabilised.
Completion date	04/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. Age range: 18 - 65, both males and females 2. Primary diagnosis of an anxiety disorder NOS according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; 300.00) 3. Severity of anxiety for the inclusion: the Hamilton Anxiety Scale (HAM-A) total score >=18, Item 1 "anxious mood" >=2, Item 2 "insomnia" >=2 4. Severity of sleep disorders for the inclusion: Pittsburgh Sleep Quality Index (PSQI) total score >5
Key exclusion criteria	1. A decrease of 25% or more of the HAM-A total score during the screening phase 2. Any clinically important psychiatric or neurological diagnoses other than an anxiety disorder NOS within 6 month before the study 3. Risk of suicide 4. History or evidence of alcohol and/or substance abuse or dependence 5. Current use of other psychotropic drugs 6. Any unstable acute medical disorder 7. Prohibited concomitant treatment: any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquiliser, antidepressives, antiepileptics, antihistaminics 8. Long-term prophylactic treatment 9. Central-acting antihypertensive medication 10. Anti-Parkinson's medication 11. Phyto-anxiolytics 12. Muscle relaxants 13. Analgetics of opiate type 14. Anaesthetics 15. Barbiturates 16. Nootropics 17. Non-medical psychiatric treatment
Date of first enrolment	16/09/2004
Date of final enrolment	04/04/2005

Locations

Countries of recruitment

Germany

Study participating centre

Willmra-Schwabe-Strasse 4

Karlsruhe
76227
Germany

Results and Publications

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