Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
1 other identifier
observational
1,483
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedMay 22, 2017
May 1, 2017
1.9 years
June 9, 2011
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
Interventions
Eligibility Criteria
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
You may qualify if:
- Patients with depression or in a depressed state
- Patients who start taking paroxetine at 20mg a day
You may not qualify if:
- Patients who have been treated with paroxetine prior to this investigation
- Patients with hypersensitivity to paroxetine
- Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
- Concomitant use in patients taking pimozide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 10, 2011
Study Start
April 1, 2006
Primary Completion
March 1, 2008
Study Completion
June 1, 2008
Last Updated
May 22, 2017
Record last verified: 2017-05