Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Saliva cotinine, Fagerstrom Test for Nicotine Dependence
研究概览
简要总结
Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.
详细描述
This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia, on stable antipsychotic dose for at least one month
- •Ages 18-65 inclusive
- •Overweight (body mass index of 25 kg/m2 or greater)
- •Daily cigarette smoker (by self-report)
排除标准
- •Inability to provide informed consent
- •Treatment refractory schizophrenia
- •Current treatment with clozapine
- •Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
- •Documented poor compliance with oral antipsychotic medication
结局指标
主要结局
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
次要结局
- Weight
- Serum glucose and lipids
- Rating of symptom severity using the PANSS
- Ratings and instrumental measures of motor functioning