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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 events

Efficacy 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

Page last updated: August 23, 2015

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