CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Atomoxetine +2 moredrug
Likely dose
Atomoxetine up to 1.8 mg/kg/day once daily in capsule formulation for 8 weeksAI-extracted
Key inclusion· 8
  • ✓Meets ADHD criteria on DISC, clinical interview, and clinical consensus conference
  • ✓ADHD is primary disorder with symptoms present for at least 9 months
  • ✓ADHD-IV-Rating Scale score ≥1.5 standard deviations above age and sex norms
  • ✓Children's Global Assessment Scale score ≤55
Key exclusion· 7
  • ✕Currently taking other psychotropic medications or other CNS-active medications
  • ✕Currently being treated effectively with atomoxetine
  • ✕Major medical conditions that might interfere with study medications
  • ✕History of or current clinically significant kidney illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00254462
NCT00254462Phase 4Completed
CompareCT.gov

Pharmacological Treatment of ADHD in Young Children

University of Nebraska·interventional·Posted Nov 16, 2005·Updated Oct 2, 2023

In Brief

A Phase 4 clinical trial evaluating Atomoxetine, Placebo, and 1 other intervention for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 93 participants across 3 sites.

Detailed Summary

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2005
Enrollment StartOct 1, 2005
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.6 years ago

Interventions

Atomoxetinedrug

Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation.

Placebodrug

Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation.

Parent Trainingbehavioral

All children will receive parent training for the duration of the study.