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Completed

NCT Number: NCT01371461

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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Key information

Conditions

Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 10, 2011
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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