Paroxetine drops for the switch-therapy in patients chronic users of Benzodiazepines: an experience in Community Medicine - ND

ITALFARMACO0 个研究点开始时间: 2009年3月20日最近更新: 2012年3月19日

试验速览

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•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.
•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) yes
•F.1.3.1 Number of subjects for this age range

•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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