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

November 4, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75019
        • Recruiting
        • Robert Debre Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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:

  • 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

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inattention scores in ADHD-RS parents
Time Frame: 8 weeks

Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
8 weeks
Hyperactivity/impulsivity scores in ADHD-RS parents
Time Frame: 8 weeks

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inattention scores in ADHD-RS parents
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 4 and 8 weeks

CGI-S (Clinical Global Impression - Severity) score
4 and 8 weeks
CGI-I (Clinical Global Impression - Improvement) score
Time Frame: 4 and 8 weeks

CGI-I (Clinical Global Impression - Improvement) score
4 and 8 weeks
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
Time Frame: 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)
Time Frame: 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
Time Frame: 8 weeks

tolerance of treatment: Blood sample: Blood count
8 weeks
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
Time Frame: 8 weeks

tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
8 weeks
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
Time Frame: 8 weeks

tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
8 weeks
tolerance of treatment: Blood sample: total bilirubin
Time Frame: 8 weeks

tolerance of treatment: Blood sample: total bilirubin
8 weeks
tolerance of treatment: Blood sample: conjugated bilirubin
Time Frame: 8 weeks

tolerance of treatment: Blood sample: conjugated bilirubin
8 weeks
tolerance of treatment: Blood sample: ionogram
Time Frame: 8 weeks

tolerance of treatment: Blood sample: ionogram
8 weeks
tolerance of treatment: Blood sample: urea
Time Frame: 8 weeks

tolerance of treatment: Blood sample: urea
8 weeks
tolerance of treatment: Blood sample: creatinine
Time Frame: 8 weeks

tolerance of treatment: Blood sample: creatinine
8 weeks
tolerance of treatment: Blood sample: T4
Time Frame: 8 weeks

tolerance of treatment: Blood sample: T4
8 weeks
tolerance of treatment: Blood sample: TSH
Time Frame: 8 weeks

tolerance of treatment: Blood sample: TSH
8 weeks
Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)
Time Frame: 4 and 8 weeks

the criterion used will be the theta-beta ratio.
4 and 8 weeks
Robert Debré patients: qualitative study:
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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