Generalized Anxiety Disorder
Conditions
Interventions
Product Name: Lavendelöl WS 1265
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lavender oil Ph. Eur.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharma
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 for the inclusion in the run-in and into the acute treatment phase: 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 Covi Anxiety Scale total score more or equal than 9 These criteria have to be met at Screening and Baseline. 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 (intra-uterine devices or condom combined with oral or injectable contraception). 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
Exclusion criteria
Exclusion criteria: 1. Any axis I diagnosis (except the study indication - GAD) within 6 months before the study entry. 2. Patient with a 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) at Screening and Baseline visit: HAMD item 1 "depressed mood" more or equal than 2, HAMD 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. Shizophrenia 7. Current use of other psychotropic drugs within 30 days of baseline visit.* 8. History of hypersensitivity to Lavender preparations. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find the optimal dose of Lavender oil WS 1265 in the treatment of patients with generalized anxiety disorder and to establish the lower end of the clinical effective dose range. The change of the HAM-A total score between baseline and end of active treatment period is compared between the treatment groups and used as the primary outcome variable. ;Secondary Objective: To compare the responder rates between the treatment groups whereby responders are defined as: - At least 50% reduction of the HAM-A total score between baseline and end of active treatment period; - Total score of the HAM-A below 10 points at the end of the active treatment period. Clinical Global Impression (CGI), SF-36 Health Survey Questionnaire, Sheehan Disability Scale, Visual Analogue Scale (VAS) Raskin Depression Scale Covi Anxiety Scale ;Primary end point(s): change of HAM-A total score between baseline and end of treatment (protocol section 12.2) | — |
Countries
Germany
Outcome results
None listed