Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity (SulfoTDAH)
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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:
- Inattention and hyperactivity/impulsivity symptoms assessed by parents using the ADHD-RS;
- Social interactions using the SRS scale (Social Responsiveness Scale);
- Emotional dysregulation using the SDQ (Strength and Difficulties Questionnaire);
- Global functioning using the CGI-S (Clinical Global Impression - Severity) and the CGI-I (Clinical Global Impression - Improvement).
To assess the effect of treatment with sulforaphane versus placebo on attention and inhibition at 4 and 8 weeks: using a specific neuropsychological assessment: CPT (Continuous Performance Test); symptoms of inattention and hyperactivity/impulsivity assessed by the teacher using the ADHD-RS self-questionnaire. Differences in behaviour may be observed depending on the context (school versus family). It is therefore important to have 2 sources of information for the ADHD-RS questionnaire: the parents and the teacher.
To assess the tolerability of treatment with sulforaphane from a clinical point of view (use of a PAERS (Paediatrician Adverse Events Rating Scale) and a biological point of view (blood count, AST, ALT, total and conjugated bilirubin, blood ionogram, urea, creatininemia, T4, TSH).
The subgroup of patients included in the Robert Debré Hospital will have a High Resolution Electroencephalogram (HR-EEG) in order to study the electroencephalographic markers of response to treatment with sulforaphane.
An interview to assess interest in and satisfaction with the treatment will be conducted with the parents (Robert Debré) and the child in the month following the end of the study as part of a qualitative study.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Eric ACQUAVIVA, PhD
- Номер телефона: +33 0140034092
- Электронная почта: eric.acquaviva@aphp.fr
Места учебы
-
-
-
Paris, Франция, 75019
- Рекрутинг
- Robert Debre Hospital
-
Контакт:
- Eric ACQUAVIVA, MD, PhD
- Номер телефона: +3340034092
- Электронная почта: eric.acquaviva@aphp.fr
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Sulforaphane
Prostaphane® is a dietary supplement based on SULFODYNE®, a broccoli seed extract standardised in free, stabilised sulforaphane. Patients will receive treatment for 8 weeks at the following dosage:
Each capsule contains 10mg of Sulforaphane. |
taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane |
|
Плацебо Компаратор: Placebo
Patients will receive treatment for 8 weeks at the following dosage:
Each capsule contains placebo. |
taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Inattention scores in ADHD-RS parents
Временное ограничение: 8 weeks
|
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
8 weeks
|
|
Hyperactivity/impulsivity scores in ADHD-RS parents
Временное ограничение: 8 weeks
|
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
8 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Inattention scores in ADHD-RS parents
Временное ограничение: 2, 4 and 12 weeks
|
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
2, 4 and 12 weeks
|
|
Hyperactivity/impulsivity scores in ADHD-RS parents
Временное ограничение: 2, 4 and 12 weeks
|
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
2, 4 and 12 weeks
|
|
Social Responsiveness Scale (SRS) scores and sub-scores
Временное ограничение: 4, 8 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
Временное ограничение: 2, 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)
Временное ограничение: 4 and 8 weeks
|
Sustained attention and inhibition scores in the CPT (Continuous Performance Test) |
4 and 8 weeks
|
|
CGI-S (Clinical Global Impression - Severity) score
Временное ограничение: 4 and 8 weeks
|
CGI-S (Clinical Global Impression - Severity) score |
4 and 8 weeks
|
|
CGI-I (Clinical Global Impression - Improvement) score
Временное ограничение: 4 and 8 weeks
|
CGI-I (Clinical Global Impression - Improvement) score |
4 and 8 weeks
|
|
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
Временное ограничение: 4 and 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)
Временное ограничение: 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: Blood count
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: Blood count |
8 weeks
|
|
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase) |
8 weeks
|
|
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase) |
8 weeks
|
|
tolerance of treatment: Blood sample: total bilirubin
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: total bilirubin |
8 weeks
|
|
tolerance of treatment: Blood sample: conjugated bilirubin
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: conjugated bilirubin |
8 weeks
|
|
tolerance of treatment: Blood sample: ionogram
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: ionogram |
8 weeks
|
|
tolerance of treatment: Blood sample: urea
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: urea |
8 weeks
|
|
tolerance of treatment: Blood sample: creatinine
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: creatinine |
8 weeks
|
|
tolerance of treatment: Blood sample: T4
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: T4 |
8 weeks
|
|
tolerance of treatment: Blood sample: TSH
Временное ограничение: 8 weeks
|
tolerance of treatment: Blood sample: TSH |
8 weeks
|
|
Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)
Временное ограничение: 4 and 8 weeks
|
the criterion used will be the theta-beta ratio. |
4 and 8 weeks
|
|
Robert Debré patients: qualitative study:
Временное ограничение: one month post treatment
|
The exploration criterion will be an in-depth description of the experience of the families and the child with regard to treatment with sulforaphane (interest and satisfaction). |
one month post treatment
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- APHP230862
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .