Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
|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|
|Primary Completion Date :||March 2008|
|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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371474
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|