Attention-deficit hyperactivity disorder (ADHD)
Conditions
Interventions
Trade Name: Equasym XL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298-59-9
Concentration unit: mg milligram(s)
Concentration type: range
Concentr
Sponsors
Afdeling Klinische Neuropsychologie Vrije Universiteit Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Diagnosis of AD(H)D according to DSM-IV or ICD-10 ii. Current treatment or to-be initiated treatment with methylphenidate to reduce ADHD symptoms iii. Age between 8 and 13 years iv. IQ above 70 v. Sufficient knowledge of the Dutch language (child and parent/caregiver) Are the trial subjects under 18? yes Number of subjects for this age range: 100 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: i. Psychiatric disorder other than ADHD, oppositional defiant disorder, conduct disorder, anxiety disorder or learning disorder ii. Neurological impairment iii. Medication other than methylphenidate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH. ;Secondary Objective: Secondary objectives are to explore the relation between academic effort and engagement and academic ability, resulting in a clearer description of the construct of academic activity which is a frequently used outcome variable in many clinical studies. Furthermore, the relation between behaviour, cognition, motivation and academic activity will be studied in children between 8-13 years old. A comparison between children with ADHD and healthy controls will be made to investigate whether the relationship between these variables differs between these groups. ;Primary end point(s): Improvements in academic effort and engagement, improvements in academic abilities (math, spelling and reading), decreased ADHD behaviours, reduced cognitive and motivational deficits;Timepoint(s) of evaluation of this end point: 31-12-2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactPromovendus / PhD Student
Afdeling Klinische Neuropsychologie Vrije Universiteit Amsterdam
Outcome results
None listed