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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prescribed PAXIL | Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 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 overall improvement | 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. | 12 weeks |
| Efficacy evaluation based on severity by symptoms | 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. | 12 weeks |
| Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II) | 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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