NCT00264654已完成3 期
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 -
- •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 -
- •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 -
- •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.
结局指标
主要结局
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
时间窗: 52 Weeks
次要结局
- 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)
研究者
研究点 (3)
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