View Clinical Trial (Medical Research Study)

Atomoxetine, Placebo and Parent Management Training in Autism - NCT00844753-(Clinical Trial 272254)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Pittsburgh
State:  
PA
Zip Code:
Conditions: Autism - Pervasive Developmental Disorder Not Otherwise Specified - Asperger's Disorder - Attention Deficit Hyperactivity Disorder
Purpose: 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 summary:
Criteria: 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
Study is available at: University of Pittsburgh Medical Center
Pittsburgh, PA
United States

Primary Contact:
Sarah McAuliffe-Bellin
Email: mcauliffebellinsj@upmc.edu
Phone: 412-235-5447

Secondary Contact:
Benjamin L. Handen, PhD
Email: HandenBL@msx.upmc.edu
Phone: 412-235-5445
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.