Atomoxetine, Placebo and Parent Management Training in Autism

Attention Deficit Hyperactivity Disorder Clinical Trial

— Strattera  

Official title:

Atomoxetine, Placebo and Parent Management Training in Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844753
• Other study ID #: 1RO1MH079082-01A2
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2008
• Last updated: January 5, 2016
• Start date: October 2008
• Est. completion date: April 2014

Study information

• Verified date: January 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Other known NCT identifiers

• NCT00699205

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's Disorder
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Hyperkinesis
• Pervasive Development Disorder

Intervention

Drug:
• atomoxetine
atomoxetine
• Placebo
Placebo + parent management treatment

Behavioral:
• Parent Management Training

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Ohio State University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

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,

Chowdhury M, Aman MG, Scahill L, Swiezy N, Arnold LE, Lecavalier L, Johnson C, Handen B, Stigler K, Bearss K, Sukhodolsky D, McDougle CJ. The Home Situations Questionnaire-PDD version: factor structure and psychometric properties. J Intellect Disabil Res. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents	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.	week 10	No
Primary	Percentage of Participants Who Were Autism Spectrum Disorder Respondents	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),	week 10	No