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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Drug: Paroxetine

• Study Type: Observational
• Enrollment (Actual): 390

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients prescribed PAXIL; Patients with depression or depressed state prescribed PAXIL during study period	Drug: Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (ACTUAL): July 1, 2004
• Study Completion (ACTUAL): October 1, 2004

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (ESTIMATE): June 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: 112304