Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change From Baseline in Weight
研究概览
简要总结
The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
详细描述
The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.
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
- •Schizophrenia or schizoaffective Disorder
- •Taking olanzapine or clozapine for at least 6 months
- •Weight gain of 7% over baseline or BMI greater than or equal to 27
排除标准
- •Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
- •Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
- •Current treatment with other medications for weight loss unless weight stable for 6 months
- •Mental Retardation
- •Alcohol or Substance Dependence within the last 6 months
- •Pregnancy
- •Alcohol or Substance Abuse within the lat month
- •Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment
结局指标
主要结局
Change From Baseline in Weight
时间窗: Weekly for 24 weeks
Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.
次要结局
- Chemistry Panel(baseline, 10 weeks and 24 weeks)
- Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.(24 weeks)
- Vital Signs(Weekly for 24 weeks)
研究者
Robert Buchanan
Chief, Maryland Psychiatric Research Center, Outpatient Research Program
University of Maryland, Baltimore