Multi-center, double-blind, randomized, reference-controlled study to prove the efficacy, safety and tolerability of Lavender oil WS 1265 (Lavandula angustifolia) in patients with generalized anxiety disorder
- Conditions
- Generalized Anxiety DisorderMedDRA version: 8.1Level: LLTClassification code 10018105Term: Generalized anxiety disorder
- Registration Number
- EUCTR2006-000521-61-DE
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 531
1.Primary diagnosis of Generalized Anxiety Disorder (GAD) according to ICD-10 (F41.1) / DSM-IV (300.02)
2. Age: 18 to 65 years.
3. Out-patient treatment by a general practitioner or a specialized physician.
4. Severity of anxiety:
HAM-A total score more or equal than 18 and
Item 1 „anxious mood more or equal than 2 and
Item 2 tension” more or equal than 2 and
HAMA subscore psychic anxiety less or equal than 21
Covi Anxiety Scale total score more or equal than 9
5. Written informed consent in accordance with the legal requirement.
6. Readiness and ability on the part of the patient to comply with the physician´s instructions and to fill in the self-assessment scales.
7. Negative pregnancy test within 7 days before Baseline visit in females of childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilization or hysterectomy at least three months before study start).
8. Use of adequate double contraception by female with childbearing potential (oral or injectable contraception or hormonal intra-uterine system IUS combined with condom).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Any axis I diagnosis (except the study indication GAD and major depression, see criterion 2) within 6 months before the study entry.
2. Patient with current or recent history of major depression (within 6 months of study entry).
3. Patient with predominant and/or severe depressive symptoms (e.g. not meeting the DSM-IV MDD criteria):
HAM-D item 1 depressed mood more or equal than 2,
HAM-D total score more than 17,
Raskin Depression Scale total score more than 7.
4. Risk of suicide.
HAMD item 3 suicide” more or equal than 2
5. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within last 6 months before the study.
6. Schizophrenia
7. Current use of other psychotropic drugs within 30 days of baseline visit.
8. History of hypersensitivity to Lavender preparations or to paroxetin.
9. Any unstable acute medical disorder.
10. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment (specified in section 6). The following medication is not allowed during the study:
- any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquilizer, antidepressives, antiepileptics, antihistaminics
- long-term prophylactic treatment (e.g. lithium, carbamazepine)
- central-acting antihypertensive medication
- antiparkinson medication
- phyto-anxiolytics
- muscle relaxants
- analgetics of opiate type
- anesthetics
- barbiturates
- nootropics.
11. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) during the course of the study.
12. Treatment with any other investigational drug in the last 12 weeks before screening.
13. Clinical significant abnormality of ECG and/or laboratory value(s).
14. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results.
15. Pregnancy, lactation.
16. Participation in any previous clinical study with Lavender oil WS 1265.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To prove the efficacy of Lavender oil WS 1265 as compared to placebo in the treatment of patients with generalized anxiety disorder.<br>The change of the HAM-A total score between baseline and Week 10 is compared between the treatment groups and used as the primary outcome variable.<br>;Secondary Objective: To compare paroxetin and placebo and Lavender oil WS 1265 and paroxetin with regard to the primary and secondary efficacy variables.<br><br>To compare the responder and remitter rates between the treatment groups whereby responders and remitters are defined as:<br>- At least 50% reduction of the HAM-A total score between baseline and Week 10 (response);<br>- Total score of the HAM-A below 10 points at Week 10 (remission).<br>;Primary end point(s): The change of the HAM-A total score between baseline and Week 10.<br>
- Secondary Outcome Measures
Name Time Method