Long-term Study Of Paroxetine in Women and Men

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

Official Title
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Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>

Conditions
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Social Phobia

Intervention / Treatment
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* Drug: BRL29060A
* Drug: paroxetine hydrochloride hydrate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BRL29060A|nan|
|Drug: paroxetine hydrochloride hydrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment. |  | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social, (SAD), Anxiety, Disorder