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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01482026

Enrollment

173

Registered

2011-11-30

Start date

2011-11-30

Completion date

2015-12-31

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Attention deficit, ADHD rating scale IV

Brief summary

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.

Interventions

OTHERADHD Rating Scale-IV

ADHD Rating Scale-IV test

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Evolution of the ADHD rating scale IV inattention subscore	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

Measure	Time frame	Description
Evolution of the ADHD rating scale IV global score	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.
Evolution of the ADHD rating scale IV hyperactivity subscore	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026