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

Conditions: Anxiety states
MedDRA version: 9.1Level: LLTClassification code 10066549Term: Chronic anxiety

Registration Number: EUCTR2008-000880-40-IT

Lead Sponsor: ITALFARMACO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.
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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the advantages derived from an SSRI added to the educational program of gradual benzodiazepines tapering in a clinical practical context.;Secondary Objective: To show the progression of depressive and anxiuos simptomatology both in treated and untreated patients with paroxetine.;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.

Secondary Outcome Measures