Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2005-12-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Paroxetine hydrochloride hydrate
Eligibility Criteria
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Inclusion Criteria
* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
* Patients have a minimum score of 60 on the LSAS total score.
Exclusion Criteria
* Patients with a history or complication of schizophrenia and bipolar disorder
* Patients with a complication of body dysmorphic disorder.
* Patients with evidence of substance abuse (alcohol or drugs)
* substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
* Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
* Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
* Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
* Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
* Patients with a history or complication of cancer or malignant tumor.
* Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.
18 Years
64 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
, ,
Countries
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Other Identifiers
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PIR104776
Identifier Type: -
Identifier Source: org_study_id
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