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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Eric ACQUAVIVA, PhD
- Telefonní číslo: +33 0140034092
- E-mail: eric.acquaviva@aphp.fr
Studijní místa
-
-
-
Paris, Francie, 75019
- Nábor
- Robert Debre Hospital
-
Kontakt:
- Eric ACQUAVIVA, MD, PhD
- Telefonní číslo: +3340034092
- E-mail: eric.acquaviva@aphp.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Komparátor placeba: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Inattention scores in ADHD-RS parents
Časové okno: 8 weeks
|
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
8 weeks
|
|
Hyperactivity/impulsivity scores in ADHD-RS parents
Časové okno: 8 weeks
|
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents |
8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Inattention scores in ADHD-RS parents
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 4 and 8 weeks
|
CGI-S (Clinical Global Impression - Severity) score |
4 and 8 weeks
|
|
CGI-I (Clinical Global Impression - Improvement) score
Časové okno: 4 and 8 weeks
|
CGI-I (Clinical Global Impression - Improvement) score |
4 and 8 weeks
|
|
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
Časové okno: 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)
Časové okno: 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
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: Blood count |
8 weeks
|
|
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase) |
8 weeks
|
|
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase) |
8 weeks
|
|
tolerance of treatment: Blood sample: total bilirubin
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: total bilirubin |
8 weeks
|
|
tolerance of treatment: Blood sample: conjugated bilirubin
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: conjugated bilirubin |
8 weeks
|
|
tolerance of treatment: Blood sample: ionogram
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: ionogram |
8 weeks
|
|
tolerance of treatment: Blood sample: urea
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: urea |
8 weeks
|
|
tolerance of treatment: Blood sample: creatinine
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: creatinine |
8 weeks
|
|
tolerance of treatment: Blood sample: T4
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: T4 |
8 weeks
|
|
tolerance of treatment: Blood sample: TSH
Časové okno: 8 weeks
|
tolerance of treatment: Blood sample: TSH |
8 weeks
|
|
Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)
Časové okno: 4 and 8 weeks
|
the criterion used will be the theta-beta ratio. |
4 and 8 weeks
|
|
Robert Debré patients: qualitative study:
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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