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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mental Disorders

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

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome:

Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice

Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II)

Efficacy evaluation based on overall improvement

Efficacy evaluation based on severities of specific symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 2004
Last updated: June 16, 2011

Page last updated: August 23, 2015

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