NCT01825798已完成3 期
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Body Mass Index Z-score
研究概览
简要总结
The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.
详细描述
This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism Spectrum Disorder (autistic disorder, pervasive developmental disorder not otherwise specified), Asperger's disorder) based upon an Autism Diagnostic Observation Scale (ADOS) and Diagnostic and Statistical Manual (DSM-IV) interview.
- •Minimum of 1 month on a stable atypical antipsychotic dose with no plans to change the dose for the next 4 months.
- •A documented greater than/equal to 7% increase in BMI since starting atypical antipsychotic therapy(going back as far as prior 12 months); or, if BMI is greater or equal to 85th percentile corrected for age and sex, then a greater than 5% body weight increase per year (prorated at greater than 5% body weight increase if medicated for longer than a year).
- •Age 6 years to 17 years, 4 months.
- •Subjects and their parents (guardians) must be judged reliable for medication compliance and must agree to keep appointments for study visits and tests as outlined in the protocol.
- •Prior to the conduct of any study-specific procedures, the subject must provide assent to participate in the study (if developmentally appropriate), and their parents (guardians) must provide written informed consent.
排除标准
- •History of intolerable adverse effects with metformin.
- •Prior history of an exposure to metformin of sufficient dose or duration to determine response status.
- •History of liver disease, renal impairment, congestive heart failure, pernicious anemia, any other condition increasing the risk for lactic acidosis, or any serious medical illness requiring treatment.
- •Use of cationic drugs excreted by the kidneys.
- •Planned surgery or procedure requiring contrast.
- •Pregnant at screening contact.
- •On other psychotropic concomitant medications for less than 2 months.
- •Treatment or planned treatment with concomitant medications with unacceptable interactions with metformin, including topiramate, levetiracetam, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, diuretics, or histamine H2 receptor antagonists.
- •Unable to tolerate blood work.
- •Current use of medication for target symptoms of appetite or weight loss.
- •Planned change of medication, medication dose, or behavioral treatment targeting weight loss during the study period.
研究组 & 干预措施
Placebo Hydrochloride Oral Solution
Placebo Comparator
干预措施: Placebo (Drug)
Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Body Mass Index Z-score
时间窗: Baseline, 16 Weeks
次要结局
- Changes in Additional Body Composition Parameters (Absolute Change in Weight)(Baseline, 16 Weeks)
- Changes in Additional Body Composition Parameters (Abdominal Circumference)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (HDL)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (Triglycerides)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (Glucose)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (Insulin)(Baseline, 16 Weeks)
- Changes in Additional Body Composition Parameters (Relative Change in Weight)(Baseline, 16 Weeks)
- Changes in Additional Body Composition Parameters (Absolute BMI)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (LDL)(Baseline, 16 Weeks)
- Changes in Additional Body Composition Parameters (Hip Circumference)(Baseline, 16 Weeks)
- Changes in Fasting Metabolic Parameters (Total Cholesterol)(Baseline, 16 Weeks)
研究者
研究点 (4)
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