NCT00793780已完成不适用
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Body Weight From Baseline
研究概览
简要总结
The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 to 70
- •Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
- •Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
- •Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months
排除标准
- •Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
- •A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
- •Not capable of giving informed consent for participation in this study
- •Ongoing pregnancy
- •Known sensitivity to naltrexone
- •A medical disorder that is known to cause obesity
- •Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
- •Impaired liver functions (greater than 3 times the upper limit of normal)
- •Diagnosed with polycystic ovary syndrome
- •Currently being treated with insulin
- •Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain
研究组 & 干预措施
Naltrexone 25mg
Active Comparator
干预措施: Naltrexone 25mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change in Body Weight From Baseline
时间窗: 8 weeks
Weight was measured with shoes off to the nearest 0.1 kg.
次要结局
- Change in Questionnaire on Craving for Sweet or Rich Foods Score(baseline and week 8)
- Insulin Levels(baseline and week 8)
- LDL Cholesterol(baseline and week 8)
- Fasting Serum Glucose Lab Values(baseline and 8 weeks)
- PANSS- Positive and Negative Symptom Scale(8 weeks)
研究者
研究点 (1)
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