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

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ClinicalTrials.gov Identifier: NCT01371461
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Mental Disorders Drug: Paroxetine

Study Design
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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Study Start Date : January 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : October 2004

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients prescribed PAXIL
Patients with depression or depressed state prescribed PAXIL during study period
 Drug: Paroxetine


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II) [ Time Frame: 12 weeks ]
    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).

  3. Efficacy evaluation based on overall improvement [ Time Frame: 12 weeks ]
    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).

  4. Efficacy evaluation based on severities of specific symptoms [ Time Frame: 12 weeks ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01371461


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01371461    
Other Study ID Numbers: 112304
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
 Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors