Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Completed

• Conditions: Panic Disorder
• Interventions: Drug: Paroxetine

• Registration Number: NCT01371474
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-03
• Study Completion: 2008-06
• 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: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1483

Inclusion Criteria

• Patients with depression or in a depressed state
• Patients who start taking paroxetine at 20mg a day

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed PAXIL	Paroxetine	Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)	12 weeks	The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).
Efficacy evaluation based on overall improvement	12 weeks	The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.
Efficacy evaluation based on severity by symptoms	12 weeks	At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.
Incidence of adverse events	12 weeks	Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice