Ziprasidone for the Treatment of Refractory Social Anxiety Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Brief Social Phobia Scale(BSPS)
研究概览
简要总结
The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone
详细描述
This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18-65 years of age
- •primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
- •minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
- •minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
- •written informed consent
- •negative serum pregnancy test for women of childbearing potential
- •normal EKG
排除标准
- •current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
- •any current primary anxiety disorder other than SAD
- •current primary depression
- •history of substance abuse or dependence within the last 3 months
- •suicide risk or serious suicide attempt within the last year
- •clinically significant medical condition or laboratory or EKG abnormality
- •women of childbearing potential who are unwilling to practice an acceptable method of contraception
- •patients needing concurrent use of psychotropic medications
- •history of hypersensitivity to sertraline or ziprasidone
- •recent (less than 2 months) initiation of psychotherapy for SAD
- •history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
- •patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra
研究组 & 干预措施
Open Label Treatment
8 weeks of open label treatment with sertraline
干预措施: Sertraline (Drug)
Randomization Ziprasidone
8 weeks of treatment with sertraline augmented with ziprasidone
干预措施: Ziprasidone (Drug)
Randomization Ziprasidone
8 weeks of treatment with sertraline augmented with ziprasidone
干预措施: Sertraline (Drug)
Randomization Placebo
8 weeks of treatment with sertraline augmented by placebo
干预措施: Sertraline (Drug)
结局指标
主要结局
Brief Social Phobia Scale(BSPS)
时间窗: Baseline, 8 and 16 weeks
An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.
次要结局
未报告次要终点