E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized Anxiety Disorder |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018105 |
E.1.2 | Term | Generalized anxiety disorder |
|
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 prove the efficacy of Lavender oil WS 1265 as compared to placebo in the treatment of patients with generalized anxiety disorder. 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.
|
|
E.2.2 | Secondary objectives of the trial |
To compare paroxetin and placebo and Lavender oil WS 1265 and paroxetin with regard to the primary and secondary efficacy variables.
To compare the responder and remitter rates between the treatment groups whereby responders and remitters are defined as: - At least 50% reduction of the HAM-A total score between baseline and Week 10 (response); - Total score of the HAM-A below 10 points at Week 10 (remission).
|
|
E.2.3 | Trial contains a sub-study | No |
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: 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).
|
|
E.4 | Principal exclusion criteria |
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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The change of the HAM-A total score between baseline and Week 10.
|
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
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 | No |
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
|
The clinical trial will be terminated when the follow-up of the preplanned number of patients is completed. The clinical trial is concluded - on reaching the target number of patients, - if the criteria for completion after the interim analysis are met.
A further inclusion of patients into the trial is to be stopped after the planned number of patients for the interim analysis is reached until the results of the interim analysis are available.
|
|
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 | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |