Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

April 22, 2015

Study Completion Date

April 22, 2015

Conditions
Fetal Alcohol SyndromeAttention Deficit Disorder With Hyperactivity (ADHD)Attention Deficit Disorder (ADD)
Interventions
DRUG

Strattera

escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy

DRUG

Placebo

0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast.

Trial Locations (1)

73117

OU Child Study Center, Oklahoma City

All Listed Sponsors
collaborator

Mark L. Wolraich, M.D.

UNKNOWN

collaborator

Eli Lilly and Company

INDUSTRY

lead

University of Oklahoma

OTHER

NCT00417794 - Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD | Biotech Hunter | Biotech Hunter