Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Disorder
Intervention: Paroxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Study design: Time Perspective: Prospective
Primary outcome: Incidence of adverse eventsEfficacy evaluation based on overall improvement Efficacy evaluation based on severity by symptoms Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2006
Last updated: June 9, 2011
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