Status:
COMPLETED
Atomoxetine, Placebo and Parent Management Training in Autism
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
University of Pittsburgh
Ohio State University
Conditions:
Autism
Pervasive Development Disorder
Eligibility:
All Genders
5-14 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00844753
Start Date
October 1 2008
End Date
April 1 2014
Last Update
February 4 2016
Active Locations (3)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642
2
Ohio State University
Columbus, Ohio, United States
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States