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 |
| Secondary identifying numbers | 750201.01.013 |
- 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
Scientific
Willmra-Schwabe-Strasse 4
Karlsruhe
76227
Germany
Study information
| Study design | Phase III, multi-centre, double-blind, randomised, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Silexan® |
| Primary outcome measure | 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 study start date | 16/09/2004 |
| Completion date | 04/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
76227
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Strasse 4
Karlsruhe
76227
Germany
"ROR" |
https://ror.org/043rrkc78 |
|---|
Funders
Funder type
Industry
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
