Last updated: 11/03/2018 12:50:33

Special Drug Use Investigation for PAXIL Tablet (Investigation in case of administered from 20mg/day)

GSK study ID
112308
See study documents
Clinicaltrials.gov ID
NCT01371474
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for PAXIL Tablet (Investigation in case of administered from 20mg/day)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of adverse events

Timeframe: 12 weeks

Efficacy evaluation based on overall improvement

Timeframe: 12 weeks

Efficacy evaluation based on severity by symptoms

Timeframe: 12 weeks

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

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paroxetine
    • Enrollment:
    1483
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Panic Disorder
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    April 2006 to June 2008
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    None
    • Patients with depression or in a depressed state
    • Patients who start taking paroxetine at 20mg a day
    • Patients who have been treated with paroxetine prior to this investigation
    • Patients with hypersensitivity to paroxetine
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-17-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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