Plain English Summary
Background and study aims:
Silexan is an essential oil produced from fresh Lavandula angustifolia flowers. The objective of the study is to show that Silexan is effective and safe in treating mixed anxiety and depression, where the main symptoms are low mood, prominent anxiety, loss of interest with associated symptoms, restlessness and tension and disturbed sleep.
Who can participate?
Adult male and female patients (aged 18 65 years) with symptoms of anxiety and depression.
What does the study involve?
One group of the patients will receive Silexan for 10 weeks. The other group will take a placebo (dummy) instead. During the study the severity of the symptoms of the disease will be measured using established scales. The scales are either self-reported or will be assessed by a trained assessor.
What are the possible benefits and risks of participating?
The participants who receive verum can expect an improvement of their symptoms of anxiety and depression. There are no know risks of using lavender oil active ingredients.
Where is the study run from?
From about 30 medical centres in Germany.
When is the study starting and how long is it expected to run for?
The study will start in October 2012 and will run for about 15 months until the required number of 300 patients have been recruited and treated.
Who is funding the study?
Dr. Willmar Schwabe GmbH & Co. KG, Germany
Who is the main contact?
Dr. Stephan Klement
Stephan.klement@schwabe.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.035
Study information
Scientific title
Multi-center, double-blind, placebo-controlled, randomized phase III study to prove the efficacy, safety and tolerability of Silexan (WS®1265) in patients with mixed anxiety and depressive disorder
Acronym
Study hypothesis
The objective of the study is to prove the efficacy of Silexan (WS®1265) in the treatment of patients with mixed anxiety and depressive disorder in comparing the change of the HAMA total score and the MADRS total score between baseline and Week 10 between Silexan and placebo.
Ethics approval
Ethik-Kommission bei der Medizinischen Fakultät der Universität Würzburg, 14 September 2012 ref: 180/12_ff
Study design
Multi-center double-blind placebo-controlled randomized phase IIIb study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mixed anxiety and depressive disorder
Intervention
80 mg/day Silexan or placebo for 70 days
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
The change of the HAMA total score and the MADRS total score
Secondary outcome measures
1. Response criteria (50 % reduction; remission) based on the HAMA total score and on the MADRS total score
2. Items 2 (tension) and 14 (behaviour at interview) of the HAMA, change and response
3. Single items and subscores of the Hamilton Rating Scale for Anxiety
4. Single items of the MADRS
5. State-Trait Anxiety Inventory (STAI)
6. Total score, subscores state anxiety and trait anxiety, early improvement on day 3
7. Subscales of the Sheehan Disability Scale (SDS) and subscores of the SF-36
8. Clinical Global Impressions
9. Hospital Anxiety and Depression Scale (HADS), total score change, subscore depression and subscore anxiety
Overall trial start date
29/10/2012
Overall trial end date
31/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of mixed anxiety and depressive disorder (ICD-10, F41.2)
2. Age 18 to 65 years
3. HAMA total score ≥ 18 with item 1 anxious mood ≥ 2 (moderate) and item 6 depressed mood ≥ 2 (moderate)
4. BMI between 18 and 29.9 kg/m2
5. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Any clinically important psychiatric or neurological diagnoses, other than study indication, within 6 month before the study
2. Risk of suicide (MADRS item 10 ≥ 2 during study) or previous suicide attempt or clear display of auto-aggressive behaviour
3. History or evidence of alcohol and/or substance abuse or dependence
4. Current use of other psychotropic drugs within 30 days before baseline visit
5. History of hypersensitivity to Lavender preparations
6. Any unstable acute medical disorder
7. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment
8. Non-medical psychiatric treatment during the course of the study
9. Clinical significant abnormality of ECG and/or laboratory values
10. Pregnancy, lactation
Recruitment start date
29/10/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Bezirk Unterfranken
Werneck
97444
Germany
Sponsor information
Organisation
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Sponsor details
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. (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