Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Inattention scores in ADHD-RS parents
研究概览
简要总结
ADHD is a neurodevelopmental disorder. It is the most common neurodevelopmental disorder in children and adolescents. Its prevalence is estimated at 5.9% in this population. The symptoms of ADHD combine attention deficit with behavioural disorders such as hyperactivity and impulsivity. Current treatment for ADHD is based on psychotherapeutic and psychoeducational measures aimed at improving behaviour and its impact on the family, social and school environment. Drug treatments may also be used, depending on the impact of the disorder and the effectiveness of alternative treatments. Psychostimulants such as amphetamine derivatives and methylphenidate are around 80% effective.
Sulforaphane is an active substance derived from broccoli that has already been tested in the treatment of other neurodevelopmental disorders. The main hypothesis is that sulforaphane is effective in treating the symptoms of Attention Deficit Disorder with or without Hyperactivity (ADHD) in children.
详细描述
This is a randomised controlled trial with a double-blind control group. The aim is to test the efficacy of Sulforaphane versus placebo by comparing these two groups with a 1:1 ratio.
The primary objective is to evaluate the efficacy of sulforaphane treatment versus placebo on the total inattention and hyperactivity/impulsivity score measured by the ADHD-RS scale (parents) at 8 weeks in children aged 6 to 12 years suffering from ADHD.
The primary endpoint was the ADHD-RS parent inattention and hyperactivity/impulsivity score at 8 weeks.
Secondary objectives:
To assess the efficacy of sulforaphane treatment versus placebo at 2, 4 and 8 weeks in children aged 6-12 years with ADHD on:
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)
盲法说明
placebo
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12
- •Diagnosis of ADHD according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
- •Followed or hospitalised in an investigating centre
- •Consent of holders of parental authority
- •Patient covered by health insurance (social security or CMU)
- •Patients able to swallow capsules
排除标准
- •Allergy to broccoli
- •Psychotropic treatment including methylphenidate in the month prior to inclusion
- •Ongoing psychotherapeutic and/or psycho-educational treatment specific to ADHD
- •ASD (Autism Spectrum Disorder) according to DSM-5 criteria, intellectual disability (IQ< 80)
- •Chronic neurological disease, epilepsy
- •Holders of parental authority under guardianship or curatorship
- •Previous intake of sulforaphane
- •Known hypothyroidism or current thyroid treatment
- •Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, where applicable
- •Patient under AME (state medical aid)
结局指标
主要结局
Inattention scores in ADHD-RS parents
时间窗: 8 weeks
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Hyperactivity/impulsivity scores in ADHD-RS parents
时间窗: 8 weeks
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
次要结局
- CGI-S (Clinical Global Impression - Severity) score(4 and 8 weeks)
- Inattention scores in ADHD-RS parents(2, 4 and 12 weeks)
- Hyperactivity/impulsivity scores in ADHD-RS parents(2, 4 and 12 weeks)
- Social Responsiveness Scale (SRS) scores and sub-scores(4, 8 and 12 weeks)
- Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score(2, 4, 8 and 12 weeks)
- Sustained attention and inhibition scores in the CPT (Continuous Performance Test)(4 and 8 weeks)
- CGI-I (Clinical Global Impression - Improvement) score(4 and 8 weeks)
- tolerance of treatment: Blood sample: Blood count(8 weeks)
- ADHD-RS teacher inattention and hyperactivity/impulsivity scores(4 and 8 weeks)
- tolerance of treatment: Adverse events score: PAERS (Paediatrician Adverse Events Rating Scale)(4 and 8 weeks)
- tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)(8 weeks)
- tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)(8 weeks)
- tolerance of treatment: Blood sample: total bilirubin(8 weeks)
- tolerance of treatment: Blood sample: conjugated bilirubin(8 weeks)
- tolerance of treatment: Blood sample: ionogram(8 weeks)
- tolerance of treatment: Blood sample: urea(8 weeks)
- tolerance of treatment: Blood sample: creatinine(8 weeks)
- tolerance of treatment: Blood sample: T4(8 weeks)
- tolerance of treatment: Blood sample: TSH(8 weeks)
- Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)(4 and 8 weeks)
- Robert Debré patients: qualitative study:(one month post treatment)