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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 9, 2011
Last updated: May 19, 2017
Last verified: May 2017
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.

Condition Intervention
Panic Disorder Drug: Paroxetine

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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

  • 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.

  • 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.

  • 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).

Enrollment: 1483
Study Start Date: April 2006
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed PAXIL
Patients with depression or in a depressed state starting PAXIL at 20 mg/day during study period
Drug: Paroxetine


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Japanese subjects with depression or in a depressed state who are considered appropriate to prescribe paroxetine tablet starting at 20mg/day according to the prescribing information

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01371474

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

Responsible Party: GlaxoSmithKline Identifier: NCT01371474     History of Changes
Other Study ID Numbers: 112308
Study First Received: June 9, 2011
Last Updated: May 19, 2017

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental 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 August 16, 2017