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

NCT06594536 | Not Yet Recruiting

• 1 other identifier: APHP230862
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Attention Deficit Disorder

Keywords

Sulforaphane

Outcome Measures

Primary Outcomes (2)

• Inattention scores in ADHD-RS parents

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

  8 weeks

• Hyperactivity/impulsivity scores in ADHD-RS parents

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

  8 weeks

Secondary Outcomes (21)

• Inattention scores in ADHD-RS parents

  2, 4 and 12 weeks

• Hyperactivity/impulsivity scores in ADHD-RS parents

  2, 4 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

  2, 4, 8 and 12 weeks

• Sustained attention and inhibition scores in the CPT (Continuous Performance Test)

  4 and 8 weeks

Study Arms (2)

Sulforaphane

EXPERIMENTAL

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: * 1 capsule/day up to 50 kg, * 2 capsules/day from 50.1 to 90 kg; * 3 capsules/day above 90 kg, Each capsule contains 10mg of Sulforaphane.

Dietary Supplement: Sulforaphane

Placebo

PLACEBO COMPARATOR

Patients will receive treatment for 8 weeks at the following dosage: * 1 capsule/day up to 50 kg, * 2 capsules/day from 50.1 to 90 kg; * 3 capsules/day above 90 kg, Each capsule contains placebo.

Other: Placebo

Interventions

Sulforaphane DIETARY_SUPPLEMENT

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

Sulforaphane

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Allergy to broccoli
• 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
• Patient under AME (state medical aid)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Eric ACQUAVIVA, PhD

CONTACT

0140034092; eric.acquaviva@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share