Mental Disorders
Conditions
Brief summary
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.
Interventions
DRUGParoxetine
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice | 12 weeks | — |
| Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II) | 12 weeks | The investigator asked the patient to fill out a set of self-administered BDI-II forms at each time of the patient's visits to the medical center (Patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL). |
| Efficacy evaluation based on overall improvement | 12 weeks | The investigator comprehensively assessed the general condition of the patient at each time of the patient's visits to the medical center and rated the condition on a seven-grade eight-category scale (7 grades of markedly improved, moderately improved, slightly improved, unchanged, slightly worsened, worsened and severely worsened; a category of unassessable). |
| Efficacy evaluation based on severities of specific symptoms | 12 weeks | The investigator rated the severities of depressed mood, anxiety, feeling irritated, hypobulia, physical symptoms and sleep disorder on a four-grade scale (none, mild, moderate and severe) based on the interview and the results of BDI-II at each time of the patient's visits to the medical center (patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL). |
Outcome results
None listed