Attention Deficit DisorderSulfoTDAHNCT06594536
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
A study testing Sulforaphane in people with Attention Deficit Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Robert Debre Hospital
Paris, 75019
Eric ACQUAVIVA, MD, PhD, +3340034092, eric.acquaviva@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Attention Deficit Disorder
- Being tested
- Sulforaphane, Placebo
- Keywords
- Sulforaphane
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDietary supplement
taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane
PlaceboOther
taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention scores in ADHD-RS parents
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Measured: 8 weeks
Hyperactivity/impulsivity scores in ADHD-RS parents
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Measured: 8 weeks
Secondary outcomes (21)
Inattention scores in ADHD-RS parents
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Measured: 2, 4 and 12 weeks
Hyperactivity/impulsivity scores in ADHD-RS parents
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Measured: 2, 4 and 12 weeks
Social Responsiveness Scale (SRS) scores and sub-scores
Social Responsiveness Scale (SRS) scores and sub-scores
Measured: 4, 8 and 12 weeks
Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score
Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score
Measured: 2, 4, 8 and 12 weeks
Sustained attention and inhibition scores in the CPT (Continuous Performance Test)
Sustained attention and inhibition scores in the CPT (Continuous Performance Test)
Measured: 4 and 8 weeks
CGI-S (Clinical Global Impression - Severity) score
CGI-S (Clinical Global Impression - Severity) score
Measured: 4 and 8 weeks
CGI-I (Clinical Global Impression - Improvement) score
CGI-I (Clinical Global Impression - Improvement) score
Measured: 4 and 8 weeks
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
Measured: 4 and 8 weeks
tolerance of treatment: Adverse events score: PAERS (Paediatrician Adverse Events Rating Scale)
tolerance of treatment: Adverse events score: PAERS (Paediatrician Adverse Events Rating Scale)
Measured: 4 and 8 weeks
tolerance of treatment: Blood sample: Blood count
tolerance of treatment: Blood sample: Blood count
Measured: 8 weeks
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
Measured: 8 weeks
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
Measured: 8 weeks
tolerance of treatment: Blood sample: total bilirubin
tolerance of treatment: Blood sample: total bilirubin
Measured: 8 weeks
tolerance of treatment: Blood sample: conjugated bilirubin
tolerance of treatment: Blood sample: conjugated bilirubin
Measured: 8 weeks
tolerance of treatment: Blood sample: ionogram
tolerance of treatment: Blood sample: ionogram
Measured: 8 weeks
tolerance of treatment: Blood sample: urea
tolerance of treatment: Blood sample: urea
Measured: 8 weeks
tolerance of treatment: Blood sample: creatinine
tolerance of treatment: Blood sample: creatinine
Measured: 8 weeks
tolerance of treatment: Blood sample: T4
tolerance of treatment: Blood sample: T4
Measured: 8 weeks
tolerance of treatment: Blood sample: TSH
tolerance of treatment: Blood sample: TSH
Measured: 8 weeks
Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)
the criterion used will be the theta-beta ratio.
Measured: 4 and 8 weeks
Robert Debré patients: qualitative study:
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).
Measured: one month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594536
- Sponsor's protocol ID
- APHP230862
- Acronym
- SulfoTDAH
- Status last verified
- Nov 2026
- First submitted
- 30 Aug 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
- ClinicalTrials.gov ID
- NCT06594536
- Acronym / sponsor ID
- SulfoTDAH / APHP230862
- Conditions
- Attention Deficit Disorder
- Keywords
- Sulforaphane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane | Experimental | Dietary Supplement: SulforaphaneProstaphane® 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. |
| Placebo | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphanetaken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane | Dietary supplement | Sulforaphane |
| Placebotaken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo | Other | Placebo |
Primary outcome
Inattention scores in ADHD-RS parents
Time frame: 8 weeks
Inattention scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
Hyperactivity/impulsivity scores in ADHD-RS parents
Time frame: 8 weeks
Hyperactivity/impulsivity scores in ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale) parents
21 secondary outcomes
Inattention scores in ADHD-RS parents
Time frame: 2, 4 and 12 weeks
Hyperactivity/impulsivity scores in ADHD-RS parents
Time frame: 2, 4 and 12 weeks
Social Responsiveness Scale (SRS) scores and sub-scores
Time frame: 4, 8 and 12 weeks
Strength and Difficulties Questionnaire (SDQ) emotional dysregulation sub-score
Time frame: 2, 4, 8 and 12 weeks
Sustained attention and inhibition scores in the CPT (Continuous Performance Test)
Time frame: 4 and 8 weeks
CGI-S (Clinical Global Impression - Severity) score
Time frame: 4 and 8 weeks
CGI-I (Clinical Global Impression - Improvement) score
Time frame: 4 and 8 weeks
ADHD-RS teacher inattention and hyperactivity/impulsivity scores
Time frame: 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: Blood sample: Blood count
Time frame: 8 weeks
tolerance of treatment: Blood sample: ASAT (Aspartate aminotransferase)
Time frame: 8 weeks
tolerance of treatment: Blood sample: ALAT (Alanin aminotransferase)
Time frame: 8 weeks
tolerance of treatment: Blood sample: total bilirubin
Time frame: 8 weeks
tolerance of treatment: Blood sample: conjugated bilirubin
Time frame: 8 weeks
tolerance of treatment: Blood sample: ionogram
Time frame: 8 weeks
tolerance of treatment: Blood sample: urea
Time frame: 8 weeks
tolerance of treatment: Blood sample: creatinine
Time frame: 8 weeks
tolerance of treatment: Blood sample: T4
Time frame: 8 weeks
tolerance of treatment: Blood sample: TSH
Time frame: 8 weeks
Robert Debré patients: EEG-HR (High Resolution Electroencephalogram)
Time frame: 4 and 8 weeks
Robert Debré patients: qualitative study:
Time frame: one month post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Attention Deficit Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric ACQUAVIVA, PhD (0140034092 ext. +33, eric.acquaviva@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inattention scores in ADHD-RS parents (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.