NCT00182455终止4 期
Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clinical Global Impression - Improvement (CGI-I) ≤ 2
研究概览
简要总结
SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. This study will test the efficacy of adding topiramate to a subject's current SSRI in cases of GSP which are considered to be treatment-resistant.
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
- Quadruple (Participant, Care Provider, 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
- •Outpatient with primary DSM-IV GSP
- •Completion of an adequate trial (14 wks) of open, flexible dose SSRI treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day)
- •Non or partial response to SSRI treatment (CGI-S > 4, LSAS > 40)
排除标准
- •Any other DSM-IV Axis I primary diagnosis
- •Meeting DSM-IV criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse
- •A lifetime history of bipolar affective disorder
- •A Hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders
- •Borderline/antisocial personality disorder
- •A comorbid Axis II cluster A personality disorder
- •Hx of > 3 adequate trials with an SSRI
- •score of > 4 on MADRS q.10
- •Current increased risk of suicide
- •Prior use of or an allergy to topiramate
- •Participation in any clinical trial 30 days prior to entering the study
- •Unable to tolerate being free of or shows signs of withdrawal benzodiazepines for 4 weeks
- •Hx of seizures, kidney stones or thyroid problems
- •BMI < 20
研究组 & 干预措施
1
Experimental
Topiramate 25 - 400 mg/day x 12 weeks
干预措施: Topiramate (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Global Impression - Improvement (CGI-I) ≤ 2
时间窗: 12 weeks
Mean change in Liebowitz Social Anxiety Scale (LSAS)
时间窗: 12 weeks
次要结局
- Beck Depression Inventory(12 weeks)
- Social Phobia Scale(12 weeks)
- Social Phobia Inventory(12 weeks)
- Clinical Global Impression -Severity(12 weeks)
- Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale(12 weeks)
- Montgomery Asberg Depression Rating Scale(12 weeks)
- Beck Anxiety Inventory(12 weeks)
研究者
研究点 (1)
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