Last updated: 11/07/2018 04:40:04

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

GSK study ID
112304
See study documents
Clinicaltrials.gov ID
NCT01371461
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 (20mg-Clinical Symptom Progression)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 12 weeks

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

Timeframe: 12 weeks

Efficacy evaluation based on overall improvement

Timeframe: 12 weeks

Efficacy evaluation based on severities of specific symptoms

Timeframe: 12 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paroxetine
    • Enrollment:
    390
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Kunitoshi Kamijima, Jun Nakamura, Koji Tsuboi, Teruhiko Higuchi. Review of the Efficacy and Safety of Paroxetine - from the Results of Post-marketing Surveillance. Japanese Journal of Clinical Psychopharmacoloogy Rinsho Seishin Yakuri. 2007;10(6):1045-1061.
    Teruhiko Higuchi, Hajime Maeda, Motoji Kawai, Kazuhiko Sugita, Yasuyuki Uechi, Tsutae Nagata. Effect of Paroxetine Hydrochloride Hydrate (Paxil Tablets) on Improvement of Clinical Symptoms in Patients with Depression and / or Depressive Episodes. Jpn Pharmacol Ther. 2005;33:489-502.
    Medical condition
    Mental Disorders
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    January 2004 to October 2004
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    None
    • Subjects who is 18 years or more
    • Subjects diagnosed with depression or in a depressed state
    • Subjects who have been treated with paroxetine prior to this investigation
    • Subjects with hypersensitivity to paroxetine
    Inclusion and exclusion 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

    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
    2004-25-10

    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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