Last updated: 02/04/2020 19:20:05

Drug Use Investigation for PAXIL Controlled-Release (CR)

GSK study ID
116488
See study documents
Clinicaltrials.gov ID
Not applicable
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: Drug Use Investigation for PAXIL Controlled-Release (CR)
Trial description: This post-marketing surveillance study (PMS) is conducted to collect and assess information on the safety and efficacy of paroxetine CR tablets in the actual use condition in patients with depression or depressive state.
(PAXIL is a registered trademark of the GlaxoSmithKline group of companies.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Changes in Clinical Global Impressions of Improvement (CGI-I) scores

Timeframe: 8 weeks

Number of patients with adverse drug reactions

Timeframe: 8 weeks

Changes in Clinical Global Impressions of Severity (CGI-S) scores

Timeframe: 8 weeks

Patient’s satisfaction

Timeframe: 8 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paroxetine CR
    • Enrollment:
    3431
    Primary completion date:
    2014-25-02
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Terufumi Hara, Masaki Kato, Takeshi Kimura,Toshifumi Kimura .Safety and effectiveness of controlled-release paroxetine in routine clinical practice: Results of a post-marketing surveillance study of patients with depression.Neuropsychiatr Dis Treat.2015;11:435-452
    Medical condition
    Depressive Disorder
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    July 2012 to February 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients with depression or depressive state
    • Patients who are treated with paroxetine CR tablets for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with depression or depressive state
    • Patients who are treated with paroxetine CR tablets for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2014-25-02
    Actual study completion date
    2014-25-02

    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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