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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 9, 2011
Last updated: June 16, 2011
Last verified: June 2011
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 Intervention
Mental Disorders
Drug: Paroxetine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]
  • 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).

  • 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).

  • 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).

Enrollment: 390
Study Start Date: January 2004
Study Completion Date: October 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed PAXIL
Patients with depression or depressed state prescribed PAXIL during study period
Drug: Paroxetine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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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Please refer to this study by its identifier: NCT01371461

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT01371461     History of Changes
Other Study ID Numbers: 112304
Study First Received: June 9, 2011
Last Updated: June 16, 2011

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
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 processed this record on May 23, 2017