Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.013
Study information
Scientific title
Acronym
Study hypothesis
To prove the efficacy of Silexan® (a lavender oil preparation) in patients suffering from an anxiety disorder not otherwise specified (NOS).
Ethics approval
Ethics Committee of the State Medical Chamber of Baden-Württemberg (Landesärztekammer Baden-Württemberg). Date of approval: 15/06/2004 (ref: 093-04)
Study design
Phase III, multi-centre, double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Silexan®
Primary outcome measures
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
Secondary outcome measures
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.
Overall trial start date
16/09/2004
Overall trial end date
04/04/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
16/09/2004
Recruitment end date
04/04/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Willmra-Schwabe-Strasse 4
Karlsruhe
76227
Germany
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & 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