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Completed

NCT Number: NCT01482026

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

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.

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Key information

Conditions

Epilepsy Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie pédiatrique, CHU d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ADHD Rating Scale-IV

Other

ADHD Rating Scale-IV test

Primary outcomes

  1. Evolution of the ADHD rating scale IV inattention subscore

    Time frame: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks

    Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.

Secondary outcomes

  1. Evolution of the ADHD rating scale IV global score

    Time frame: Change from baseline in ADHD rating scale IV global score at 12 to16 weeks

    Evolution of the ADHD rating scale IV global score in treated versus non treated patients, after 12 to 16 weeks.

  2. Evolution of the ADHD rating scale IV hyperactivity subscore

    Time frame: Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks

    Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 30, 2011
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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