Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
This study has been completed.
Information provided by:
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)|
Resource links provided by NLM:
Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine MesylateU.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||April 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
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