Panic Disorder
Conditions
Brief summary
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.
Interventions
DRUGParoxetine
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 12 weeks | Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice |
| Efficacy evaluation based on overall improvement | 12 weeks | The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL. |
| Efficacy evaluation based on severity by symptoms | 12 weeks | At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders. |
| Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II) | 12 weeks | The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment). |
Outcome results
None listed