CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 171 enrolled
Drug / intervention
OROS-Methylphenidate and placebo for inattentive type pts +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01727414
NCT01727414Phase 4Completed

Medication Response in Children With Predominately Inattentive Type ADHD

Children's Hospital Medical Center, Cincinnati·interventional·Posted Nov 16, 2012·Updated May 18, 2021

In Brief

A Phase 4 clinical trial evaluating OROS-Methylphenidate and placebo for inattentive type pts and OROS-Methylphenidate and placebo for combined type pts for ADHD - Inattentive Type and ADHD - Combined Type. Completed, enrolled 171 participants across 1 site.

Detailed Summary

This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD) respond to medication, and if their response is different from children who have problems with both hyperactivity and inattention. In order to do this, children ages 7-11 whose primary difficulty is with attention problems and who have never been on behavioral or psychiatric medications are being recruited. Once enrolled, children will try one week each of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit, Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly assigned to one of six possible medication dose and placebo titration schedules, but the study doctor, family, and teacher will not know which dose (if any) children are receiving for a given week. Each week, behavioral and side effect ratings will be completed by both the child's parent and teacher, and the family will meet with the study doctor for a physical examination and to discuss how each week went. Some children will also have neuropsychological testing to determine how methylphenidate influences their working memory, sustained attention, and ability to inhibit (stop) inappropriate responses. All data will be analyzed to decide which medication dose the child responded to best and further recommendations for treatment will be given. Ultimately, this study aims to improve understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant medications by * determining whether these children experience a diminished response to methylphenidate compared to children with both hyperactivity and inattention * determining whether certain genetic and environmental factors play a role in this response. Findings from this study will be used to help streamline the identification of the most effective doses of medication for children with ADHD-Primarily Inattentive Type.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 16, 2012
Enrollment StartJun 1, 2006
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 13.6 years ago

Interventions

OROS-Methylphenidate and placebo for inattentive type ptsdrug

Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.

OROS-Methylphenidate and placebo for combined type ptsdrug

Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.