Overview

This trial is active, not recruiting.

Conditions autism, pervasive development disorder, asperger's disorder, attention deficit hyperactivity disorder
Treatments atomoxetine, placebo, parent management training
Phase phase 4
Sponsor University of Rochester
Collaborator University of Pittsburgh
Start date October 2008
End date June 2014
Trial size 144 participants
Trial identifier NCT00844753, 1RO1MH079082-01A2, NCT00699205

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Atomoxetine + Parent Management Training
atomoxetine
atomoxetine
parent management training
(Active Comparator)
Atomoxetine without Parent Management Training
atomoxetine
atomoxetine
(Placebo Comparator)
Placebo + Parent Management Training
placebo
Placebo + parent magagement treatment
parent management training
(Placebo Comparator)
Placebo without Parent Management Training
placebo
Placebo + parent magagement treatment

Primary Outcomes

Measure
Effectiveness of atomoxetine vs Placebo for children with Autism or PDDNOS who exhibit symptoms of ADHD
time frame: 10 weeks

Secondary Outcomes

Measure
Compare effectiveness of atomoxetine + PMT relative to atomoxetine alone in children who exhibit symptoms of ADHD
time frame: 10 weeks

Eligibility Criteria

Male or female participants from 5 years up to 14 years old.

Inclusion Criteria: - Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria, - Mental age equal to or greater than 24 months, - ADHD symptoms based upon the CASI and clinical confirmed diagnosis, - CGIS-S rating of 4 or grater for ADHD symptoms, - A mean item score of >1.5 on both the Parent and Teacher (non-parent caregiver) SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms must be cross-situational), - Reliable care provider available to bring subject to clinic visits and weekly sessions. Exclusion Criteria: - DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder NOS,bipolar disorder, or major depression (if accompanied by a family history of bipolar disorder) based upon evidence of suicidality, CASI, and clinical interview/history, - Prior failed adequate trial of atomoxetine, - Use of other psychotropic medications that produce CNS effects, - Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular disease, narrow angle glaucoma, other significant physical illness, - Pregnancy or sexually active females (intercourse in the past 6 months, reported by either the subject or caregiver), - Currently on effective medication treatment for ADHD, - Prior involvement in Parent Management Training or other similar program, - Currently on albuterol or taking beta blockers, - Taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study

Additional Information

Official title Atomoxetine, Placebo and Parent Management Training in Autism
Principal investigator Benjamin Handen, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Rochester.