Last updated: 02/04/2020 19:20:05
Drug Use Investigation for PAXIL Controlled-Release (CR)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2014-25-02
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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