E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066549 |
E.1.2 | Term | Chronic anxiety |
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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 study the advantages derived from an SSRI added to the educational program of gradual benzodiazepines tapering in a clinical practical context. |
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E.2.2 | Secondary objectives of the trial |
To show the progression of depressive and anxiuos simptomatology both in treated and untreated patients with paroxetine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Treatment with either alprazolam, bromazepam, etizolam, delorazepam, diazepam or lorazepam for at least 3 mounths. 2. HAMA (Hamilton Anxiety scale)score ≤ 15. 3. HAMD (Hamilton Depression scale) score ≤ 15. 4. Medical condition stable and drug regimens unchanged for longer than 3 mounths. 5. Of both sexes. 6. Aged ≥ 18 and ≤ 70 years. 7. Having signed Informed Consent prior to initiation of any study procedure. |
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E.4 | Principal exclusion criteria |
1. Previous or concomitant psychosis or bipolar disorder or other psychiatric illness. 2. Concomitant diagnosis of Major Depressive Disorder according to DSM IV-TR criteria. 3. Suicidal thinking or behaviours 4. Epilepsy 5. Previous treatment with an antidepressant drug. 6. Pregnancy or lactation. 7. Substances abuse in the last six months or concomitant according to DSM IV-TR criteria. 8. Concomitant antidepressant or other psychiatric therapy (except benzodiazepines). 9. Hypersensitivity to paroxetine or any of the excipients 10. Concomitant therapy with monoamine oxidase inhibitors (MAOIs) or with other drugs which inhibit the hepatic enzyme CYP450 2D6. 11. Concomitant therapy with full dosage oral anticoagulants (to reach INR > 2.5) 12. Bleeding diathesis 13. Renal failure (creatinemia > 1.5 mg/dl) 14. Known active gastric or duodenal ulcer 15. Chronic treatment with NSAID (non steroidal anti-inflammatory drug). 16. Severe liver insufficiency (clinical history and lab). 17. Treatment with other investigational drugs or patient inclusion in other clinical trials |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of patients able to reduce the starting dose of benzodiazepine by almost 75% by the end of the tenth week of treatment. |
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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 | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |