Bloeddruk Attention deficit disorder with hyperactivity
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Target group: Patients with ADHD according to DSM-IV criteria (any subtype), based on clinical diagnosis, and confirmed by a structured interview [depending on local procedures: ADHD module of the K-SADS (Kaufman et al., 2000) or CAADID (Conners Adult ADHD Diagnostic Interview for DSM-IV) (www.mhs.com/) or DIVA (Diagnostic Interview for Adult ADHD) (www.divacenter.eu/Content/Downloads/DIVA_2.pdf). • Aged between 15 and 25 years. • Any comorbidity is allowed. • Any comedication is allowed. • Treated with methylphenidate (IR or ER preparations) for 3 years or longer, continuously.;Note: we will attempt to recruit at least 50% of the participants of the target group being treated continuously for 3 years with a minimum effective dose of 0.5 mg methylphenidate /kg/day). Being treated continuously means being prescribed methylphenidate continuously but may include the presence of drug holidays. We will measure adherence by asking questions about drug holidays and % of the overall dose taken. We will allow for some variation in dosages prescribed to be able to analyze dose-response relationships.;Control group: • Patients with ADHD according to DSM*IV criteria (any subtype), based on clinical diagnosis. • Aged between 15 and 25 years. • Any comorbidity is allowed. • Any comedication is allowed. • Never been treated with methylphenidate.
Exclusion criteria
Exclusion criteria: All Groups: Treatment with dexamfetamine or atomoxetine. ADHD controls: Treatment with methylphenidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Hypertension defined on the basis of 24*hour blood pressure measures as systolic and/or diastolic blood pressure of a positive value >= 1.65 (equivalent to the 95th percentile). • Left ventricular mass will be indexed by a partition. A partition value will be taken at the 95th percentile of measurements indexed to body size (whether, height, weight or body surface area). This has the attraction of simplicity and will be used as the primary outcome measure. This method essentially categorises individuals into *normal* or *increased* left ventricular mass without conveying the degree to which the abnormal measurement differs from the reference population. LVM will be indexed to the allometric height in meters raised to the power of 2.7 (g/m2.7). This been extensively reported, with a value of 38.6g/m2.7 denoting the 95th percentile (de Simone et al 1992; de Simone et al 1995). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Continuous scores of 24-hour systolic and diastolic blood pressure. • Z- scores of left ventricular mass. Z*scores record how many standard deviations above or below a size*specific population mean an individual measurement lies and has the attraction of conveying the degree of deviation of the observed measurement from the mean. This will be also assessed as a secondary outcome analysis (Foster et al 2008). LVM will be indexed for height to power of 2.7 using an online calculator (Parameter (Z), 2009). Other study parameters To meet our secondary objectives and explore the role of potential moderators, mediators and confounders, and analyze dose-response relationships, the following other study parameters will be collected: Clinical and psychiatric information • Demographic information • Family Developmental, medical and Psychiatric History • Developmental history • Medication history • Current psychiatric medication (including drug and dose) • Schooling, SES • Substance Misuse Questionnaire (including smoking and alcohol) • Lifestyle, physical exercise • Severity of ADHD (ADHD DSM-IV rating scale) • Severity of psychiatric problems (YSR / YASR) • CGI-Severity • CGAS Physical status • Weight • Height • Physical examination • Cardiac examination • Biochemistry | — |
Countries
Netherlands
Outcome results
None listed