Long-term Study Of Paroxetine in Women and Men

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2005-11-30

Brief Summary

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This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)

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Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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BRL29060A

Intervention Type DRUG

paroxetine hydrochloride hydrate

Intervention Type DRUG

Other Intervention Names

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BRL29060A

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
* Must give a written informed consent.
* 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 primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No