A Placebo-Controlled, Cross-Over Trial of Aripiprazole Added to Obese Olanzapine-Treated Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weight (Lbs)
研究概览
简要总结
This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required than a between-group design.
详细描述
Specific Aims:
This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required.
Study Procedures:
We have designed this trial to examine effects upon weight, lipids, glucose metabolism, positive symptoms, negative symptoms, and depressive symptoms. This project, examining the usefulness of combination therapy, may offer a possible intervention for patients who are obese and treated with olanzapine, but otherwise experiencing a good clinical response. Many patients, despite the medical problems that may occur, are reluctant to switch their antipsychotic agent.
Location:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Male or female
- •Age 18-65
- •Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type
- •Body mass index > 30 Kg/m2 or >27 Kg/m2 with other risk factors (HTN, Lipid abnormalities)
- •Well established compliance with outpatient medications.
- •Maintained on a stable dose of olanzapine for at least one month.
排除标准
- •Serious medical or neurological illness (unstable cardiac disease, malignancy, liver or renal impairment, etc.)
- •Current substance abuse
- •Psychiatrically unstable, which is defined as a score on the CGI's severity of illness question of 5 or greater or a baseline Total PANSS score > 75
- •Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- •Serious suicidal or homicidal risk within the past three months
研究组 & 干预措施
Aripiprazole
aripiprazole 15mg/day
干预措施: Aripiprazole (Drug)
placebo
matched placebo for aripiprazole 15mg/day
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Weight (Lbs)
时间窗: baseline, week 4
Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in Body Mass Index (BMI)
时间窗: baseline, week 4
Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in Waist-hip Ratio (WHR)
时间窗: baseline, week 4
Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in Fasting Total Cholesterol
时间窗: baseline, week 4
Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in Low-density Lipoprotein (LDL)
时间窗: baseline, week 4
Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
时间窗: baseline, week 4
Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
Change From Baseline in Triglycerides
时间窗: baseline, week 4
Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.
次要结局
未报告次要终点
研究者
David C. Henderson, MD
Associate Professor of Psychiatry
Harvard University