Special Drug Use Investigation for PAXIL Tablet (Long-term)

NCT ID: NCT01371448

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2005-09-30

Brief Summary

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This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).

Detailed Description

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Conditions

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Mental Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed PAXIL for long-term use

Patients with depression/depressed state or panic disorder prescribed PAXIL during study period

Paroxetine

Intervention Type DRUG

Interventions

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Paroxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with depression/depressed state or panic disorder
* PAXIL must be used for long-term

Exclusion Criteria

* Patients who had been taking PAXIL since before the start of the survey
* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112302

Identifier Type: -

Identifier Source: org_study_id

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