NCT00988481撤回4 期
Topiramate Augmentation in Bulimia Nervosa Partial Responders
Neuropsychiatric Research Institute, Fargo, North Dakota2 个研究点 分布在 1 个国家开始时间: 2009年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Weekly number of binge eating episodes and purging episodes
研究概览
简要总结
The goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment.
详细描述
The aim of this study is to determine whether the addition of an augmentation medication (topiramate 200mg/d) will confer additional reductions in symptomatology in BN patients who have received six weeks of standard pharmacological treatment with fluoxetine 60 mg/day or its equivalent and had a partial response but are not in symptomatic remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects meeting Diagnostic and Statistical Manual IV edition (DSM-IV) diagnostic criteria for bulimia nervosa (BN).
- •Subjects must be between the ages of 18 and 60 years.
- •Subjects must currently demonstrate partial response to a standard BN pharmacotherapy treatment.
- •Women of child-bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- •Subjects must be of good general health by history, laboratory assessment and physical exam.
- •Subject's BMI must be >20 and <27 kg/m^2.
排除标准
- •Subjects who are allergic to topiramate.
- •Subjects who meet DSM-IV criteria for anorexia nervosa.
- •Women who are pregnant or nursing at the time of study.
- •Subjects experiencing clinically significant, unstable neurological, cardiac, hepatic or renal disease or narrow angle glaucoma.
- •Subjects with a history of nephrolithiasis.
- •Subjects with a serum potassium <3.0 mmol/L
- •Subjects cannot start psychotherapy during the study.
- •Subjects currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, or bipolar disorder.
- •Subjects receiving antipsychotic agents, mood stabilizers, antianxiety agents or other non-antidepressant psychotropic agent currently.
- •Subjects currently or with a history within the past year of meeting DSM-IV diagnostic criteria for substance abuse.
- •Subjects who are experiencing clinically significant suicidal ideation (subjects will be referred to appropriate caregiver).
- •Subjects who have participated in an investigational drug study in the past 30 days.
- •Subjects who are receiving any prescription medications other than oral contraceptives that will interact with any of the study medication.
结局指标
主要结局
Weekly number of binge eating episodes and purging episodes
时间窗: Weekly for 10 weeks
次要结局
- Abstinence from BN symptoms(Baseline and endpoint (week 1 and week 10))
研究者
James Roerig
Principal investigator
Neuropsychiatric Research Institute, Fargo, North Dakota
研究点 (2)
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