Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
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|ClinicalTrials.gov Identifier: NCT01371461|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment|
|Mental Disorders||Drug: Paroxetine|
|Study Type :||Observational|
|Actual Enrollment :||390 participants|
|Official Title:||Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||October 2004|
Patients prescribed PAXIL
Patients with depression or depressed state prescribed PAXIL during study period
- Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice [ Time Frame: 12 weeks ]
- Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371461
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|