Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy

Study Overview
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Brief Summary
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The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences. In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.

Official Title
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Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

Conditions
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Epilepsy

Intervention / Treatment
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* Other: ADHD Rating Scale-IV
* Other: ADHD Rating Scale-IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 6 to 15 years and 11 months; male or female; with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria; children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate. Exclusion Criteria: Patients below 6 years old or patients older than 16 years; with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria; mental retardation defined by a score < 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated patients<br>Patients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore | Other: ADHD Rating Scale-IV<br>* ADHD Rating Scale-IV test<br>|
| Experimental: Non treated patients<br>Patients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore | Other: ADHD Rating Scale-IV<br>* ADHD Rating Scale-IV test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the ADHD rating scale IV inattention subscore | Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks. | Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the ADHD rating scale IV global score | Evolution of the ADHD rating scale IV global score in treated versus non treated patients, after 12 to 16 weeks. | Change from baseline in ADHD rating scale IV global score at 12 to16 weeks | 
| Evolution of the ADHD rating scale IV hyperactivity subscore | Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks. | Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Attention deficit, ADHD rating scale IV