CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 154 enrolled
Drug / intervention
Methylphenidate 0.15 mg/kg +5 moredrug
Likely dose
Methylphenidate 0.15–0.6 mg/kg immediate-release orallyAI-extracted
Key inclusion· 2
  • ✓Diagnosis of Attention Deficit Hyperactivity Disorder
  • ✓IQ of 80 or greater
Key exclusion· 3
  • ✕History of seizures or other neurological problems
  • ✕Medical history that would involve considerable risk in taking stimulant medication
  • ✕History or current diagnosis of pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder

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

Search/NCT00050622
NCT00050622N/ACompleted
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ADHD Treatment: Comparative and Combined Dosage Effects

Florida International University·interventional·Posted Dec 17, 2002·Updated Sep 30, 2016

In Brief

A clinical study evaluating Methylphenidate 0.15 mg/kg, Low-Intensity BMOD, and 4 other interventions for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 154 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.

Study Details

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

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2002
Enrollment StartSep 1, 2001
Primary CompletionAug 1, 2004
Study CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 23.5 years ago

Interventions

Methylphenidate 0.15 mg/kgdrug

0.15 m/kg/dose immediate-release methylphenidate

Low-Intensity BMODbehavioral

Lower-intensity behavioral treatment package.

Methylphenidate 0.3 mg/kgdrug

0.3 mg/kg/dose immediate-release methylphenidate

Placebodrug

Methylphenidate 0.6 mg/kgdrug

0.3 mg/kg/dose immediate-release methylphenidate

High Intensity BMODbehavioral

Comprehensive high-intensity Summer Treatment Program (STP)