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

NCT00417794 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-04-10

No results posted yet for this study

Summary

The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.

Conditions

  • Fetal Alcohol Syndrome
  • Attention 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.

Sponsors & Collaborators

  • Mark L. Wolraich, M.D.

    collaborator UNKNOWN

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Laura J McGuinn, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2015-04-22
Completion
2015-04-22

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417794 on ClinicalTrials.gov