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OpenTrials
Completed

NCT Number: NCT01371474

Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

The objective of this survey was to understand the safety and efficacy of PAXIL tablets ("PAXIL", hereinafter) when it was started at 20 mg/day in subjects with depression or in a depressed state.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

  • Patients with depression or in a depressed state
  • Patients who start taking paroxetine at 20mg a day

Exclusion criteria

  • Patients who have been treated with paroxetine prior to this investigation
  • Patients with hypersensitivity to paroxetine
  • Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
  • Concomitant use in patients taking pimozide

Treatment and study plan

paroxetine

Drug

Primary outcomes

  1. Incidence of adverse events

    Time frame: 12 weeks

    Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice

  2. Efficacy evaluation based on overall improvement

    Time frame: 12 weeks

    The investigator compared the general condition over 1 week before each clinical visit with that over 1 week before the start of treatment with PAXIL.

  3. Efficacy evaluation based on severity by symptoms

    Time frame: 12 weeks

    At every clinical visit, the investigator rated each of the specified symptoms including depressed mood, loss of interests/concerns, anxiety, lack of motivation, physical symptoms, and sleep disorders.

  4. Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)

    Time frame: 12 weeks

    The investigator asked each subject to fill out the self-administered form of BDI-II at every clinical visit (recommended clinical visit schedule: 1, 2, 4, 8, and 12 weeks after the start of treatment).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 10, 2011
Registry last updated
May 22, 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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