Atomoxetine, Placebo and Parent Management Training in Autism

Phase 4

Completed

Conditions: Attention Deficit Hyperactivity Disorder
Autism
Pervasive Development Disorder
Asperger's Disorder

Interventions: Drug: atomoxetine
Drug: Placebo
Behavioral: Parent Management Training

Registration Number: NCT00844753

Lead Sponsor: University of Rochester

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Parent Management Training	Atomoxetine + Parent Management Training
2	atomoxetine	Atomoxetine without Parent Management Training
3	Placebo	Placebo + Parent Management Training
3	Parent Management Training	Placebo + Parent Management Training
4	Placebo	Placebo without Parent Management Training
1	atomoxetine	Atomoxetine + Parent Management Training

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents	week 10	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	week 10	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),

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Ohio State University
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States