Atomoxetine and Parent Training for Children With Autism and Attention-Deficit/Hyperactivity Disorder: A 24-Week Extension Study.
The authors previously reported on a 2-by-2 randomized clinical trial of individual and combined treatment with atomoxetine (ATX) and parent training (PT) for attention-deficit/hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 5- to 14-year-old children with autism spectrum disorder. In the present report, they describe a 24-week extension of treatment responders and nonresponders.



One-hundred seventeen participants from the acute trial (91%) entered the extension; 84 of these were in 2 subgroups: "treatment responders" (n = 43) from all 4 groups in the acute trial, seen monthly for 24 weeks, and "placebo nonresponders" (n = 41), treated with open-label ATX for 10 weeks. Participants originally assigned to PT continued PT during the extension; the remainder served as controls. Primary outcome measurements were the parent-rated Swanson, Nolan and Pelham ADHD scale and the Home Situations Questionnaire.



Sixty percent (26 of 43) of treatment responders in the acute trial, including 68% of responders originally assigned to ATX, still met the response criteria at the end of the extension. The response rate of placebo nonresponders treated with 10-week open-label ATX was 37% (15 of 41), similar to the acute trial. Children receiving open-label ATX + PT were significantly more likely to be ADHD responders (53% versus 23%) and noncompliance responders (58% versus 14%) than those receiving open-label ATX alone.



Most ATX responders maintained their responses during the extension. PT combined with ATX in the open-label trial appeared to improve ADHD and noncompliance outcomes more than ATX alone. Clinical trial registration information-Atomoxetine, Placebo and Parent Management Training in Autism (Strattera); http://clinicaltrials.gov; NCT00844753.
Division of Neurodevelopmental and Behavioral Pediatrics at the University of Rochester, Rochester, NY. Electronic address: Tristram_Smith@URMC.Rochester.edu.
Tristram
T
Smith
Nisonger Center UCEDD, The Ohio State University, Columbus.
Michael G
MG
Aman
Nisonger Center UCEDD, The Ohio State University, Columbus.
L Eugene
LE
Arnold
Division of Neurodevelopmental and Behavioral Pediatrics at the University of Rochester, Rochester, NY.
Laura B
LB
Silverman
Nisonger Center UCEDD, The Ohio State University, Columbus.
Luc
L
Lecavalier
Nisonger Center UCEDD, The Ohio State University, Columbus.
Jill
J
Hollway
University of Pittsburgh School of Medicine.
Rameshwari
R
Tumuluru
Division of Neurodevelopmental and Behavioral Pediatrics at the University of Rochester, Rochester, NY.
Susan L
SL
Hyman
Center for Biostatistics, The Ohio State University.
Kristin A
KA
Buchan-Page
Nisonger Center UCEDD, The Ohio State University, Columbus.
Jessica
J
Hellings
Center for Biostatistics, The Ohio State University.
Robert R
RR
Rice
Center for Biostatistics, The Ohio State University.
Nicole V
NV
Brown
Center for Biostatistics, The Ohio State University.
Xueliang
X
Pan
University of Pittsburgh School of Medicine.
Benjamin L
BL
Handen
D000293:Adolescent; D000069445:Atomoxetine Hydrochloride / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000628:therapy*; D000067877:Autism Spectrum Disorder / Q000188:drug therapy / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010290:Parents / Q000193:education*; D011569:Psychiatric Status Rating Scales; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000069445:Atomoxetine Hydrochloride
atomoxetine; attention-deficit/hyperactivity disorder; autism; combined modality therapy; outcome assessment
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