Open treatment with atomoxetine for 10 weeks: •Week 1: 0,5 mg/kg/day in 1 or 2 doses. •Week 2 – 6: 1,2 mg/kg/day i 1 or 2 doses. •Week 6 – 8: Significant improvements: Continue on 1,2 mg/kg/day in 1 or 2 doses. Not improved: 1,4 mg/kg/day in 1 or 2 doses. There will be medical consultations at week 1, 2, 4, 6 and 10 weeks. Patients or parents can contact the doctor in between if needed.
Conditions
Interventions
Product Name: Strattera
Pharmaceutical Form: Capsule*
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are: • Fullfill criteria for the diagnosis Pervasive Developmental Disorder • Fullfill criteria for the diagnosis Attention Deficit Hyperactivity Disorder • Age: 6 – 18 years Are the trial subjects under 18? yes Number of subjects for this age range: 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: Cooccuring medical condition that contradict treatment with atomoxetine, e.g. allergy to the substance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Research questions are: • What percentage of patients with PDD + ADHD will show clinically signifiacnt improvemnets of their ADHD symptoms when they are treated with atomoxetine? • Are there differences in effects on symptoms of hyperactivity and impulsivity versus symptoms of inattention? • What kind of side effects are reported? ;Secondary Objective: ;Primary end point(s): Effekts of atomoxetine will be assessed by using: - ADHD Rating Scale filled out by parents and teachers - Assessment of general health,symptoms, and daily functioning by the physician at the regualar visits. - Clinical Global Improvements (CGI) At visits all ”adverse events” will be recorded. | — |
Countries
Norway
Outcome results
None listed