Clinical Trials Directory

Trials / Completed

CompletedNCT00844753

Atomoxetine, Placebo and Parent Management Training in Autism

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
128 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
All
Age
5 Years – 14 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGatomoxetineatomoxetine
DRUGPlaceboPlacebo + parent management treatment
BEHAVIORALParent Management Training

Timeline

Start date
2008-10-01
Primary completion
2014-04-01
Completion
2014-04-01
First posted
2009-02-16
Last updated
2016-02-04
Results posted
2016-02-04

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00844753. Inclusion in this directory is not an endorsement.