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

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Civil Hospices of Lyon

Status

Completed

Conditions

Epilepsy

Treatments

Other: ADHD Rating Scale-IV

Study type

Interventional

Funder types

Other

Identifiers

NCT01482026
2011.682/25

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No 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).

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

173 participants in 2 patient groups

Treated patients
Experimental group
Description:
Patients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore
Treatment:
Other: ADHD Rating Scale-IV
Other: ADHD Rating Scale-IV
Non treated patients
Experimental group
Description:
Patients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore
Treatment:
Other: ADHD Rating Scale-IV
Other: ADHD Rating Scale-IV

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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