NCT01316302已完成4 期
A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Pristiq® (Desvenlafaxine) Extended-Release Tablets in Generalized Social Anxiety Disorder
The Medical Research Network1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
详细描述
Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must give written informed consent prior to any study procedures.
- •Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator.
- •A minimum score of 60 on the LSAS total score at both Screening and Baseline visits.
- •A total HAM-D score of less than 15 at the Screening visit.
- •CGI Severity score of 4 or greater at both Screening and Baseline visits.
- •Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.
排除标准
- •An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator.
- •Any history or complication of schizophrenia or bipolar disorder.
- •Any complication of body dysmorphic disorder.
- •Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit.
- •Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception.
- •Subjects scoring >2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
- •Systolic blood pressure ≥165 and/or diastolic blood pressure ≥
- •Positive Urine Drug Screen at the Screening visit.
- •Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments.
- •Any history or complication of cancer or malignant tumor.
- •Fluoxetine within 28 days of Baseline
- •MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week.
- •Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy.
- •Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
- •Treatment refractory GSAD
研究组 & 干预措施
Pristiq
Experimental
Flexible dose, 50-100mg QD
干预措施: Pristiq (Drug)
Placebo
Placebo Comparator
Matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score
时间窗: Baseline to study endpoint (Week 12)
Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.
次要结局
- Patient Global Impression of Change(Baseline to study endpoint (Week 12))
- Clinical Global Impression of Improvement Scale (CGI-I)(Baseline to Week 12)
研究者
研究点 (1)
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