Status:
NOT_YET_RECRUITING
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Attention Deficit Disorder
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
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 combi...
Detailed Description
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 obj...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06594536
Start Date
December 1 2024
End Date
September 1 2026
Last Update
September 19 2024
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