Last updated: 11/07/2018 04:40:04
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
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 (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
Observational study model:
Other
Primary completion date:
Not applicable
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)
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
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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