NCT05416125已完成1 期
Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Percent change in Body Mass Index
研究概览
简要总结
This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.
详细描述
This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 6 to <12 years at study entry
- •Severe obesity defined as BMI >/= 1.2 times the 95th percentile at the screening visit
- •Prior failed attempt of lifestyle therapy per parent/guardian report
- •Written informed consent of parent/legal guardian and written assent of participant
排除标准
- •Contraindications to lisdexamfetamine, including current or recent (< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
- •Family history of sudden death or ventricular arrhythmia in any first or second degree relative with any of the following: sudden or unexplained death including sudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantable defibrillator).
- •Any history of fainting or seizure from exercise, startle, or fright
- •Clinically significant congenital or structural heart disease or arrhythmia
- •BMI <1.2 times the 95th percentile at the baseline/randomization visits
- •Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile (on 3 separate occasions) at the screening OR baseline/randomization visits
- •Tachycardia defined heart rate (HR) >/= 120 bpm (on 3 separate occasions) at the screening OR baseline/randomization visits
- •Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine
- •History of chemical dependency
- •Diabetes mellitus (type 1 or 2)
- •Current or recent (< 3 months) use of anti-obesity medication(s)
- •Previous bariatric surgery
- •Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s)
- •Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
- •Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN
- •Fasting glucose >/= 126 mg/dL
- •History of mania, schizophrenia, bipolar disorder, or psychosis
- •Unstable depression or anxiety that has required hospitalization in the past 12 months
- •Any history of suicide attempt
- •Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh at the screening or baseline/randomization visits
- •Children's Depressive Inventory 2 (CDE-2_ score >/= 70 (based on parent or child report) at the screening or baseline/randomization visits
- •Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort at any time during the study
- •Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential
- •Inability to swallow test capsule (participants will have two opportunities)
研究组 & 干预措施
Lifestyle therapy plus placebo
Placebo Comparator
Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.
干预措施: Lifestyle therapy (Behavioral)
Lifestyle therapy plus lisdexamfetamine
Active Comparator
Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
干预措施: Lisdexamfetamine Dimesylate (Drug)
结局指标
主要结局
Percent change in Body Mass Index
时间窗: 24 weeks
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
次要结局
未报告次要终点
研究者
研究点 (1)
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