Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Phase 3

Completed

• Conditions: ADHD

• Registration Number: NCT00141063
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study Completion: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-17
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• DSM-IV diagnosis of ADHD
• Males and females aged 6-12

Read More

Exclusion Criteria

• Inability of understand or follow instructions
• Is pregnant
• Diagnosis of tic disorder
• History of seizure disorder

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in attention and deportment measured at 2 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.

Trial Locations

Locations (1)

Center for Psychiatry & Behavioral Medicine; 🇺🇸 Las Vegas, Nevada, United States