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

This study has been completed.
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: January 5, 2016
Last verified: January 2016
  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:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents [ Time Frame: week 10 ] [ Designated as safety issue: No ]
    Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)-IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit.

  • Percentage of Participants Who Were Autism Spectrum Disorder Respondents [ Time Frame: week 10 ] [ Designated as safety issue: No ]

    Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire - Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.

    The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill),



Enrollment: 128
Study Start Date: October 2008
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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 management treatment
Behavioral: Parent Management Training
Placebo Comparator: 4
Placebo without Parent Management Training
Drug: Placebo
Placebo + parent management treatment

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Ohio State University
Columbus, Ohio, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
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

Publications:
Barkley, R. A., & Edelbrock, C. (1987). Assessing situational variation in children's problem behaviors: The Home and School Situations Questionnaires. In R. Prinz (Ed.), Advances in behavioral assessment of children and families (pp. 157-176). Greenwich, CT: JAI Press Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: November 23, 2015
Last Updated: January 5, 2016
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:
Disease
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Hyperkinesis
Asperger Syndrome
Child Development Disorders, Pervasive
Autism Spectrum Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2016