Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sulforaphane

    Dietary supplement

    taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane

  • Placebo

    Other intervention

    taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: SulforaphaneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inattention scores in ADHD-RS parents

Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents

Time frame
8 weeks
2

Hyperactivity/impulsivity scores in ADHD-RS parents

Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents

Time frame
8 weeks

Secondary outcomes

1

Inattention scores in ADHD-RS parents

Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents

Time frame
2, 4 and 12 weeks
2

Hyperactivity/impulsivity scores in ADHD-RS parents

Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents

Time frame
2, 4 and 12 weeks
3

Social Responsiveness Scale (SRS) scores and sub-scores

Social Responsiveness Scale (SRS) scores and sub-scores

Time frame
4, 8 and 12 weeks
4

Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score

Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score

Time frame
2, 4, 8 and 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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