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

4. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Paris, Frankrike, 75019
        • Rekruttering
        • Robert Debre Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Sulforaphane

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inattention scores in ADHD-RS parents
Tidsramme: 8 weeks

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

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inattention scores in ADHD-RS parents
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 4 and 8 weeks

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

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

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

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

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

tolerance of treatment: Blood sample: total bilirubin
8 weeks
tolerance of treatment: Blood sample: conjugated bilirubin
Tidsramme: 8 weeks

tolerance of treatment: Blood sample: conjugated bilirubin
8 weeks
tolerance of treatment: Blood sample: ionogram
Tidsramme: 8 weeks

tolerance of treatment: Blood sample: ionogram
8 weeks
tolerance of treatment: Blood sample: urea
Tidsramme: 8 weeks

tolerance of treatment: Blood sample: urea
8 weeks
tolerance of treatment: Blood sample: creatinine
Tidsramme: 8 weeks

tolerance of treatment: Blood sample: creatinine
8 weeks
tolerance of treatment: Blood sample: T4
Tidsramme: 8 weeks

tolerance of treatment: Blood sample: T4
8 weeks
tolerance of treatment: Blood sample: TSH
Tidsramme: 8 weeks

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

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

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Sponsor

Assistance Publique - Hôpitaux de Paris

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2024

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

30. august 2024

Først innsendt som oppfylte QC-kriteriene

10. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • APHP230862

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