Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Autism
Interventions
DRUG

Atomoxetine

Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.

DRUG

Placebo

Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.

Trial Locations (2)

46202

Christian Sarkine Autism Treatment Center at Riley Hospital for Children, Indianapolis

02421

Lurie Center - MassGeneral Hospital, Lexington

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Massachusetts General Hospital

OTHER

NCT00498173 - Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism | Biotech Hunter | Biotech Hunter