Panic Disorder MedDRA version: 9.1 Level: LLT Classification code 10033666 Term: Panic disorder
Conditions
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability of two different schedules of up-titration with paroxetine;Secondary Objective: Efficacy evaluation of the two treatments;Primary end point(s): Number of patients who discontinue the treatment (drop-out patients), number of patients complaining adverse events, total scores of SIDE and DOTES scales | — |
Countries
Italy
Outcome results
None listed