E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized Anxiety Disorder |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
change of HAM-A total score between baseline and end of treatment (protocol section 12.2) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |