Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Completed

• Conditions: Mental Disorders
• Interventions: Drug: Paroxetine

• Registration Number: NCT01371461
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-07
• Study Completion: 2004-10
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• Subjects who is 18 years or more
• Subjects diagnosed with depression or in a depressed state

Exclusion Criteria

• Subjects who have been treated with paroxetine prior to this investigation
• Subjects with hypersensitivity to paroxetine
• Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
• Concomitant use in subjects taking pimozide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed PAXIL	Paroxetine	Patients with depression or depressed state prescribed PAXIL during study period

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice	12 weeks
Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II)	12 weeks	The investigator asked the patient to fill out a set of self-administered BDI-II forms at each time of the patient's visits to the medical center (Patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL).
Efficacy evaluation based on overall improvement	12 weeks	The investigator comprehensively assessed the general condition of the patient at each time of the patient's visits to the medical center and rated the condition on a seven-grade eight-category scale (7 grades of markedly improved, moderately improved, slightly improved, unchanged, slightly worsened, worsened and severely worsened; a category of unassessable).
Efficacy evaluation based on severities of specific symptoms	12 weeks	The investigator rated the severities of depressed mood, anxiety, feeling irritated, hypobulia, physical symptoms and sleep disorder on a four-grade scale (none, mild, moderate and severe) based on the interview and the results of BDI-II at each time of the patient's visits to the medical center (patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL).