CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 232 enrolled
Drug / intervention
Atomoxetine +1 moredrug
Likely dose
Atomoxetine or methylphenidate dosing not specified in published textAI-extracted
Key inclusion· 8
  • ✓Meets DSM-IV-TR criteria for ADHD
  • ✓ADHD-RS score at least 1.5 standard deviations above age/gender mean
  • ✓CGI Severity ADHD Rating ≥4
  • ✓Currently attends school with ≥3 months remaining in high school
Key exclusion· 10
  • ✕History of atomoxetine or methylphenidate intolerance
  • ✕Any medical condition for which study medications are contraindicated
  • ✕Autism, intellectual disability, schizophrenia, psychotic disorder, bipolar disorder, severe depression, or conduct disorder
  • ✕Comorbid disorder requiring primary treatment focus

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

Search/NCT00183391
NCT00183391Phase 4Completed
CompareCT.gov

Measuring and Predicting Response to Atomoxetine and Methylphenidate

Icahn School of Medicine at Mount Sinai·interventional·Posted Sep 16, 2005·Updated Jun 6, 2018

In Brief

A Phase 4 clinical trial evaluating Atomoxetine and Methylphenidate for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 232 participants across 2 sites.

Detailed Summary

This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

Study Details

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

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJul 1, 2005
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

Atomoxetinedrug

Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.

Methylphenidatedrug

Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.