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Atomoxetine, Placebo and Parent Management Training in Autism (Strattera)

This study is currently recruiting participants.
Verified April 2013 by University of Rochester
Sponsor:
Collaborators:
University of Pittsburgh
Ohio State University
Information provided by (Responsible Party):
tristram smith, University of Rochester
ClinicalTrials.gov Identifier:
NCT00844753
First received: June 6, 2008
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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.


Condition Intervention Phase
Autism
Pervasive Development Disorder
Asperger's Disorder
Attention Deficit Hyperactivity Disorder
 Drug: atomoxetine
Drug: Placebo
Behavioral: Parent Management Training
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Atomoxetine, Placebo and Parent Management Training in Autism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Effectiveness of atomoxetine vs Placebo for children with Autism or PDDNOS who exhibit symptoms of ADHD [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare effectiveness of atomoxetine + PMT relative to atomoxetine alone in children who exhibit symptoms of ADHD [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Atomoxetine + Parent Management Training
 Drug: atomoxetine
atomoxetine
Behavioral: Parent Management Training
Active Comparator: 2
Atomoxetine without Parent Management Training
 Drug: atomoxetine
atomoxetine
Placebo Comparator: 3
Placebo + Parent Management Training
 Drug: Placebo
Placebo + parent magagement treatment
Behavioral: Parent Management Training
Placebo Comparator: 4
Placebo without Parent Management Training
 Drug: Placebo
Placebo + parent magagement treatment

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844753

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

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Carol Stamm, BA     585-275-0953     Carol_stamm@urmc.rochester.edu    
Contact: Tristram Smith, PhD     585-273-3515     Tristram_smith@urmc.rochester.edu    
Principal Investigator: Tristram Smith, PhD            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States
Contact: Michael Aman, PhD     614-688-4196     aman.1@osu.edu    
Contact: Jill A. Hollway, MA     614-247-6402     Hollway.3@osu.edu    
Principal Investigator: Michael Aman, PhD            
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Sarah McAuliffe-Bellin     412-235-5447     mcauliffebellinsj@upmc.edu    
Contact: Benjamin L. Handen, Ph.D.     412-235-5445     HandenBL@msx.upmc.edu    
Principal Investigator: Benjamin L. Handen, PhD            
Sponsors and Collaborators
University of Rochester
University of Pittsburgh
Ohio State University
Investigators
Principal Investigator: Benjamin Handen, PhD University of Pittsburgh
Principal Investigator: Michael Aman, PhD Ohio State University
Principal Investigator: Tristram Smith, PhD University of Rochester
  More Information

No publications provided

Responsible Party: tristram smith, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00844753     History of Changes
Obsolete Identifiers: NCT00699205
Other Study ID Numbers: 1RO1MH079082-01A2
Study First Received: June 6, 2008
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Autism
PDD NOS
Attention Deficit Hyperactivity Disorder
Parent Management Training

Additional relevant MeSH terms:
Autistic Disorder
Attention Deficit Disorder with Hyperactivity
Asperger Syndrome
Hyperkinesis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013