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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
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ 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).


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371461

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01371461     History of Changes
Other Study ID Numbers: 112304
Study First Received: June 9, 2011
Last Updated: June 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013