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

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371461
• Other study ID #: 112304
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 7, 2017
• Start date: January 2004
• Est. completion date: October 2004

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: October 2004
• Est. primary completion date: July 2004
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Paroxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice		12 weeks
Primary	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
Primary	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
Primary	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