Official Title: “Atomoxetine, Placebo and Parent Management Training in Autism”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2013

Intervention(s) in this Clinical Trial

• Drug: atomoxetine
  • atomoxetine
• Drug: Placebo
  • Placebo
• Behavioral: Parent Management Training

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Atomoxetine + Parent Management Training
• Active Comparator: 2
  • Atomoxetine without Parent Management Training
• Placebo Comparator: 3
  • Placebo + Parent Management Training
• Placebo Comparator: 4
  • Placebo without Parent Management Training

Primary Measures

• Effectiveness of atomoxetine vs Placebo for children with Autism or PDDNOS who exhibit symptoms of ADHD
  • Time Frame: 10 weeks
    Safety Issue?: Yes

Secondary Measures

• Compare effectiveness of atomoxetine + PMT relative to atomoxetine alone in children who exhibit symptoms of ADHD
  • Time Frame: 10 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Children 5 yrs to 13 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 13 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Rochester

Overall Clinical Trial Officials and Contacts

Benjamin Handen, PhD Principal Investigator University of Pittsburgh  

Overall Contact: Benjamin L. Handen, PhD 412-235-5445 HandenBL@msx.upmc.edu

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00844753

Study ID Number: 1RO1MH079082-01A2

ClinicalTrials.gov Identifier: NCT00844753

Health Authority: United States: Food and Drug Administration