Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594536
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SulfoTDAH
Brief Summary:
ADHD is a neurodevelopmental disorder It is the most common neurodevelopmental disorder in children and adolescents Its prevalence is estimated at 59 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
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 11 ratio
The primary objective is to evaluate the efficacy of sulforaphane treatment versus placebo on the total inattention and hyperactivityimpulsivity 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 hyperactivityimpulsivity 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 hyperactivityimpulsivity 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 hyperactivityimpulsivity 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
The primary objective is to evaluate the efficacy of sulforaphane treatment versus placebo on the total inattention and hyperactivityimpulsivity 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 hyperactivityimpulsivity 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 hyperactivityimpulsivity 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 hyperactivityimpulsivity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None