Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01371461
First received: June 9, 2011
Last updated: June 16, 2011
Last verified: June 2011

June 9, 2011
June 16, 2011
January 2004
July 2004   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).
Same as current
Complete list of historical versions of study NCT01371461 on ClinicalTrials.gov Archive Site
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Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.

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Observational
Time Perspective: Prospective
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Probability Sample

Subjects of 18 years or more diagnosed with depression or in a depressed state, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information

Mental Disorders
Drug: Paroxetine
Patients prescribed PAXIL
Patients with depression or depressed state prescribed PAXIL during study period
Intervention: Drug: Paroxetine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
October 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who is 18 years or more
  • Subjects diagnosed with depression or in a depressed state

Exclusion Criteria:

  • Subjects who have been treated with paroxetine prior to this investigation
  • Subjects with hypersensitivity to paroxetine
  • Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
  • Concomitant use in subjects taking pimozide
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT01371461
112304
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP