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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01371474
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371474

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: 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

ClinicalTrials.gov processed this record on September 18, 2014