E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10033666 |
E.1.2 | Term | Panic disorder |
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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 evaluate the tolerability of two different schedules of up-titration with paroxetine |
|
E.2.2 | Secondary objectives of the trial |
Efficacy evaluation of the two treatments |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal 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.Investigators lack of confidence on the patient compliance to fulfill the study requirements, in terms of visits / compliance to treatment |
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E.5 End points |
E.5.1 | 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 |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 |
Same IMP at two different schedules of up-titration |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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 |