At a glance
ClinicalIndex Comparison Record- ✓Age 5 years to 14 years 11 months
- ✓Clinical diagnosis of Autism, Asperger's Disorder, or PDDNOS confirmed by ADI-R and DSM-IV clinical evaluation
- ✓Mental age ≥24 months
- ✓ADHD symptoms confirmed on CASI and clinically diagnosed
- ✕DSM-IV diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder NOS, bipolar disorder, or major depression with family history of bipolar disorder
- ✕Prior failed adequate trial of atomoxetine
- ✕Use of other psychotropic medications that produce CNS effects
- ✕Diagnosis of cardiovascular disease, hypertension, narrow angle glaucoma, or other significant physical illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Atomoxetine, Placebo and Parent Management Training in Autism
In Brief
A Phase 4 clinical trial evaluating atomoxetine, Placebo, and 1 other intervention for Autism and 3 related conditions. Completed, enrolled 128 participants across 3 sites.
Detailed Summary
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.
Study Details
Timeline
Interventions
atomoxetine
Placebo + parent management treatment