Atomoxetine, Placebo and Parent Management Training in Autism
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.