Last updated: 11/03/2018 12:50:33
Special Drug Use Investigation for PAXIL Tablet (Investigation in case of administered from 20mg/day)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
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
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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