Condition category
Mental and Behavioural Disorders
Date applied
04/08/2008
Date assigned
12/09/2008
Last edited
12/09/2008
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

Dr Angelika Dienel

ORCID ID

Contact details

Willmra-Schwabe-Strasse 4
Karlsruhe
76227
Germany

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

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. 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

Publication citations

Additional files

Editorial Notes