About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Sulforaphane
Dietary supplementtaken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane
Placebo
Other interventiontaken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo
Treatment groups
Trial outcomes
Primary outcomes
Inattention scores in ADHD-RS parents
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Hyperactivity/impulsivity scores in ADHD-RS parents
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Secondary outcomes
Inattention scores in ADHD-RS parents
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Hyperactivity/impulsivity scores in ADHD-RS parents
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Social Responsiveness Scale (SRS) scores and sub-scores
Social Responsiveness Scale (SRS) scores and sub-scores
Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score
Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: