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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: Paroxetine

• Study Type: Observational
• Enrollment (Actual): 1483

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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

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 in a depressed state starting PAXIL at 20 mg/day during study period	Drug: Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	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 overall improvement	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.	12 weeks
Efficacy evaluation based on severity by symptoms	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.	12 weeks
Efficacy evaluation based on Beck Depression Inventory- Second Edition (BDI-II)	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).	12 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): June 1, 2008

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): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; 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: 112308