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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)

2026年11月4日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フランス
      • Paris、フランス、75019
        • 募集
        • Robert Debre Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年～12年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：Sulforaphane

taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane
プラセボコンパレーター：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.
他の：Placebo

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Inattention scores in ADHD-RS parents
時間枠：8 weeks

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

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Inattention scores in ADHD-RS parents
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：4 and 8 weeks

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

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

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

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

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

tolerance of treatment: Blood sample: total bilirubin
8 weeks
tolerance of treatment: Blood sample: conjugated bilirubin
時間枠：8 weeks

tolerance of treatment: Blood sample: conjugated bilirubin
8 weeks
tolerance of treatment: Blood sample: ionogram
時間枠：8 weeks

tolerance of treatment: Blood sample: ionogram
8 weeks
tolerance of treatment: Blood sample: urea
時間枠：8 weeks

tolerance of treatment: Blood sample: urea
8 weeks
tolerance of treatment: Blood sample: creatinine
時間枠：8 weeks

tolerance of treatment: Blood sample: creatinine
8 weeks
tolerance of treatment: Blood sample: T4
時間枠：8 weeks

tolerance of treatment: Blood sample: T4
8 weeks
tolerance of treatment: Blood sample: TSH
時間枠：8 weeks

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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assistance Publique - Hôpitaux de Paris

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年12月1日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2024年8月30日

QC基準を満たした最初の提出物

2024年9月10日

最初の投稿 (実際)

2024年9月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • APHP230862

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いいえ

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