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Atomoxetine, Placebo, and Parent Training in Autism (CHARTS Study)

Brief Summary of Study’s Purpose: Purpose is to conduct a study comparing the drug atomoxetine to placebo in children with autism. Participants may receive parent management training in combination with medication or in combination with placebo. Participants may receive placebo with no parent management training.

Study Type: Drug Treatment Intervention. Parent Management Training included.

Trial Sponsor: NIMH Grant

Locations and Contact Info:

COLUMBUS SITE: The Ohio State University

Identified Contact Person:
Pamela Sayre
Study Coordinator
(614) 688-8214
pamela.sayre@osumc.edu
The Ohio State University
Department of Psychiatry, Nisonger Center
Columbus, Ohio 43210

Principal Investigator’s Contact Information:
Michael G. Aman Ph.D.
Director of Research
(614) 688-4196
aman.1@osu.edu

ROCHESTER SITE: University of Rochester Medical Center

Identified Contact Person:
Carol Stamm
Study Coordinator
(585) 275-0953
carol_stamm@urmc.rochester.edu 
University of Rochester Medical Center
Dept of Pediatrics/ Division of Neurodevelopmental and Behavioral Pediatrics
Rochester, NY 14642

Principal Investigator’s Contact Information:
Tristram Smith, PhD
Director of Research
(585) 273-3515
tristram_smith@urmc.rochester.edu  
University of Rochester Medical Center

PITTSBURGH SITE: University of Pittsburgh

Identified Contact Person:
Sarah McAuliffe-Bellin, M.Ed.
Project Coordinator
(412) 235-5447
mcauliffebellinsj@upmc.edu
University of Pittsburgh
Department of Psychiatry
Center for Autism & Developmental Disorders at the John Merck Clinic
Pittsburgh, PA 15203

Principal Investigator’s Contact Information:
Benjamin L. Handen, PhD
Director of Training & Clinical Services
(412) 235-5445
handenbl@upmc.edu

Unique trial identification number:  2008H0044

Website: www.psychmed.osu.edu and www.autism-adhd.org

Eligibility Criteria:
a. Inclusion criteria:
i.    Outpatients between 5 years and 14 years, 11 months of age, inclusive
ii.   ADHD Symptoms and Diagnosis of Autistic Spectrum Disorder
iii.  Males and females;
iv.  IQ > 35Mental age greater than or equal to 24 months.
v.  Diagnosis of ADHD symptoms (combined or hyperactive-impulsive types) based upon a parent-completed DICA-IV (Reich et al., 1997) and clinician - confirmed diagnosis of ADHD symptoms;
vi. CGI Severity rating of 4 or greater for ADHD symptoms (Clinician);
vii. A score >1.5 SD above the mean (for age) on both the Parent and Teacher SNAP-IV18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms must be cross-situational); (It has been shown that parents and teachers of children with ID make an implicit correction for their intellectual handicaps (Pearson & Aman, 1994), so special provisions to adjust for those subjects with ID are not required);
viii.Care provider who can reliably bring subject to clinic visits, can attend weekly PMT sessions, can provide trustworthy ratings, and interact with subject on a regular basis.

b. Exclusion criteria:
i.  DSM-IV diagnosis of Bipolar Disorder, schizophrenia, schizoaffective disorder, or psychotic disorder NOS, based upon DICA-IV;
ii.  Prior failed adequate trial of ATX (defined as a minimum of 4 weeks on medication, with at least one week at a 1.00 mg/kg dose or greater within the last two years);
iii. Use of other psychotropic medications or medications for medical illnesses that produce CNS effects;
iv. Hypertension;
v. Other cardiovascular disease;
vi. Narrow angle glaucoma;
vii. Other significant physical illness (e.g., serious liver or renal pathology);
viii. Pregnancy or sexually active females not using a reliable method of contraception;
ixCurrently on an effective medication treatment regimen for ADHD.
x.   Prior involvement in Parent Management Training through enrollment in the Autism RUPP or other similarly standardized, systematic PMT program.  
xi. Currently on albuterol (other than by occasional inhalation) or taking beta blockers.

c. Gender: Male and Female

d. Minimum age: 5.0 years

e. Maximum age: 14 years 11 months

Number of Participants Needed: 48 participants per site

Start Date of Recruiting: May 15, 2008

Closure Date: March 24, 2013

Time Commitment Length:  10 week study followed by a 10 week open label for non responders on placebo or a 6 month extension follow up for responders

Time Commitment Frequency:
varies by appointment.

IRB study/protocol approval number2008H0044