Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
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|ClinicalTrials.gov Identifier: NCT01371474|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : May 22, 2017
|Condition or disease||Intervention/treatment|
|Panic Disorder||Drug: Paroxetine|
|Study Type :||Observational|
|Actual Enrollment :||1483 participants|
|Official Title:||Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||June 2008|
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
- Incidence of adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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).
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): NCT01371474
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|