Randomized, open-label, controlled and multicenter trial on a new pattern of Paroxetine up-titration for Panic Disorder. Comparison between two different dose regimens. - ND

• Conditions: Panic Disorder; MedDRA version: 9.1Level: LLTClassification code 10033666Term: Panic disorder

• Registration Number: EUCTR2007-000051-34-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subjects of both sexes 2.Aged ≥ 18 years 3.Suffering from Panic Disorder with or without agoraphobia, according to DSM IV-TR 4.At least two full panic attacks in the last 2 weeks before the screening visit 5.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.Other concomitant psychiatric illness 2.Suicidal thinking or behaviours 3.Previous psychosis or bipolar disorder 4.Epilepsy 5.Pregnancy or lactation 6.Substances abuse in the last six months 7.Treatment with other investigational drugs or patient inclusion in other clinical trials 8.Antidepressant or benzodiazepine or other psychiatric therapy 9.Benzodiazepines administration in the last two weeks preceding the randomization visit 10.Hypersensitivity to paroxetine or any of the excipients 11.Concomitant therapy with monoamine oxidase inhibitors (MAOIs), thioridazine or with other drugs which inhibit the hepatic enzyme CYP450 2D6 12.Concomitant therapy with full dosage oral anticoagulants (to reach INR > 2.5) 13.Bleeding diathesis 14.Renal failure (creatinemia > 1.5 mg/dl) 15.Known active gastric or duodenal ulcer 16.Severe liver insufficiency (clinical history and lab) 17.Investigator?s lack of confidence on the patient compliance to fulfill the study requirements, in terms of visits / compliance to treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified