NCT00004446已完成不适用
Study of Fluoxetine in Patients With Depersonalization Disorder
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to:
- Determine the effects of fluoxetine in the treatment of depersonalization disorder, 2) Assess the durability of treatment response in these patients, 3) Assess the improvement in psychiatric disability in these patients, and 4) Assess the effects of comorbid Axis I disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and Axis II personality disorders on treatment outcome in these patients.
详细描述
In this trial, participants will be randomly assigned to receive either fluoxetine or placebo. Treatment will consists of two phases (acute treatment and maintenance). In the acute treatment phase, participants will receive fluoxetine or placebo daily for 12 weeks. Participants will be followed every 2 weeks. In the Maintenance phase, participants showing significant improvement after 12 weeks may continue treatment for an additional 6 months. In this phase, participants are followed every 4 weeks.
Participants who do not improve during the acute treatment phase may receive open fluoxetine, or another appropriate medication, for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- 未提供
排除标准
- •Prior or concurrent bio- or chemotherapy or
- •Use of any of the following within 2 weeks prior to study entry: antipsychotics, anticonvulsants, stimulants, barbiturates, lithium, benzodiazepines, or antidepressants
- •Use of MAO inhibitors or investigational drugs within 4 weeks prior to study entry
- •History of fluoxetine use at a dose of 10 mg or more for at least 6 weeks duration
- •Hematologic, hepatic, renal, cardiovascular, pulmonary, metabolic, endocrine, systemic, or gastrointestinal disease
- •History of mental disorders
- •Current substance abuse
- •Current eating disorder
- •Current clinically unstable suicidal ideation
- •Unstable medical illness
- •Clinically unstable
- •Clinically important abnormalities in lab tests or physical exams
- •History of seizure disorders or abnormal electroencephalogram
- •Hypersensitivity or severe side effects to fluoxetine
- •Pregnancy or breast-feeding. Women of child-bearing potential must use effective contraception
研究者
研究点 (1)
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