Cognitive remediation and Attention Deficit Disorder with or without Hyperactivity (ADHD)

Phase 1

• Conditions: Attention Deficit Disorder with or without Hyperactivity; MedDRA version: 16.0Level: HLTClassification code 10003730Term: Attention deficit and disruptive behaviour disordersSystem Organ Class: 100000004873; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2012-004586-41-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patient, male or female, aged 7 to 11 years,
- Responding to current diagnostic criteria for ADHD according to DSM IV-TR,
- Presenting a total score on the ADHD-RS (ADHD Rating Scale)> 28 (before treatment),
- Stopping his supportive psychotherapy if he had begun one,
- Schooled in conventional class,
- Presenting a WISC IV total score> 80 (done maximum one year before the inclusion or at the inclusion)
- Registered to social security,
- Informed consent given by the two holders of parental authority

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Uncorrected perceptual disorder
- Subjects with a pervasive developmental disorder, psychotic disorder, characterized major depressive disorder
- Subjects who participated in research in the last 3 months
- Subjects suffering from: glaucoma, hyperthyroidism, thyrotoxicosis, heart diseases (high blood pressure, congestive heart failure, etc…), cerebrovascular disorders.
- Subjects with no deficit in the virtual classroom: having a total number of hit superior to 80 and a number of commissions inferior to 21
For the group of children with ADHD treated with methylphenidate:
- Patient stopping his treatment during the protocol
For groups of ADHD children treated with cognitive remediation, and ADHD children treated with supportive psychotherapy:
- Patients receiving treatment with psychostimulant during the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified