Attention Deficit Disorder with or without Hyperactivity MedDRA version: 16.0 Level: HLT Classification code 10003730 Term: Attention deficit and disruptive behaviour disorders System Organ Class: 100000004873
Conditions
Interventions
Trade Name: QUASYM L.P. 10 mg, gélule à libération modifiée
QUASYM L.P. 20 mg, gélule à libération modifiée
Product Name: QUASYM LP
Pharmaceutical Form: Capsule
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether a cognitive remediation program based on the virtual classroom software can be a therapeutic tool for children suffering from ADHD.;Secondary Objective: Compare children's cognitive performances on the virtual classroom software, before, during and after treatments ( cognitive remediation program or supportive psychotherapy or drug treatment) Compare children's cognitive performances on neuropsychological tests before, during and after treatments ( cognitive remediation program or supportive psychotherapy or drug treatment);Primary end point(s): Score at ADHD Rating Scale ;Timepoint(s) of evaluation of this end point: Day one and day 70 (before and after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cognitives performances in neuropsychological tests assessing executive and attentional abilities ;Timepoint(s) of evaluation of this end point: Day one and day 70 (before and after treatment) | — |
Countries
France
Contacts
Public ContactStéphanie BIOULAC
CHU de Bordeaux
Outcome results
None listed