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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

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: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371474

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01371474     History of Changes
Other Study ID Numbers: 112308
Study First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
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 April 17, 2014