Condition category
Mental and Behavioural Disorders
Date applied
04/10/2012
Date assigned
26/10/2012
Last edited
26/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Hans-Peter Volz

ORCID ID

Contact details

Bezirk Unterfranken
Balthasar-Neumann-Platz 1
Werneck
97444
Germany

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

http://www.schwabepharma.com/

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

Publication citations

Additional files

Editorial Notes