Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

NCT01371461 | Completed

• 1 other identifier: 112304
• Study Type: observational
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (4)

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

  12 weeks

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

  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).

  12 weeks

• Efficacy evaluation based on overall improvement

  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).

  12 weeks

• Efficacy evaluation based on severities of specific symptoms

  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).

  12 weeks

Study Arms (1)

Patients prescribed PAXIL

Patients with depression or depressed state prescribed PAXIL during study period

Drug: Paroxetine

Interventions

Paroxetine DRUG

Patients prescribed PAXIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects of 18 years or more diagnosed with depression or in a depressed state, who are considered appropriate to prescribe paroxetine tablet according to the prescribing information

You may qualify if:

• Subjects who is 18 years or more
• Subjects diagnosed with depression or in a depressed state

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Paroxetine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 10, 2011
• Study Start: January 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 8, 2017

Record last verified: 2017-05