CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 203 enrolled
Drug / intervention
methylphenidate HCl (Concerta)drug
Likely dose
Methylphenidate HCl (Concerta) up to 1.5 mg/kg/day (maximum 126 mg/day), titrated per clinical responseAI-extracted
Key inclusion· 3
  • ✓Age 12–17 years, adolescent outpatient
  • ✓DSM-IV ADHD diagnosis confirmed by structured interview
  • ✓Current ADHD symptoms severe enough to warrant treatment: CGI-S score ≥4 (moderately ill), OR already on Concerta with good response (CGI 1–2) and good tolerability
Key exclusion· 15
  • ✕Serious or unstable medical illness (hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease)
  • ✕Clinically significant abnormal baseline laboratory values
  • ✕History of seizures
  • ✕Active tic disorder

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

Search/NCT00181714
NCT00181714Phase 4Completed
CompareCT.gov

Prevention of Cigarette Smoking in ADHD Youth With Concerta

Massachusetts General Hospital·interventional·Posted Sep 16, 2005·Updated May 7, 2013

In Brief

A Phase 4 clinical trial evaluating methylphenidate HCl (Concerta) for ADHD. Completed, enrolled 203 participants across 1 site.

Detailed Summary

This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD. The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
CollaboratorsOrtho-McNeil Janssen Scientific Affairs, LLC

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartNov 1, 2003
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.8 years ago

Interventions

methylphenidate HCl (Concerta)drug

OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.