Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
Summary
This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta.
Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.
Description
Concerta was specifically developed to replace three times a day immediate release (IR) methylphenidate (MPH). The clinical advantages offered by this novel compound go beyond ease of administration. By avoiding the peaks and valleys of serum levels associated with IR MPH, treatment with Concerta minimizes adverse effects at peaks and break through symptoms at valleys securing clinical coverage throughout the day, minimizing the risks of adverse effects from serum fluctuations that can occur with multiple dosing of the IR formulation of MPH. This unique pharmacokinetic and pharmacodynamic profile of Concerta is potentially particularly advantageous in the treatment of adults with ADHD because a) adults with ADHD tend to be forgetful; b) forgetfulness makes the self administration of treatment three times a day difficult; c) forgetfulness can lead to poor compliance and drop off of effects over time with its attendant detrimental effect on clinical control and quality of life. Subjects will be randomized by the pharmacy to CONCERTA or to continue MPH IR TID in a ratio of 4:1.
This study includes: 1) a six-week design to document the response rate 2) assessment of the impact of either MPH IR or Concerta on functional capacities 3) careful assessment of safety and tolerability
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Conditions
Attention Deficit Hyperactivity Disorder
Intervention
methylphenidate hydrochloride, OROS methylphenidate hydrochloride (CONCERTA)
Location
Massachusetts General Hospital
Cambridge
Massachusetts
United States
02138
Status
Completed
Source
Massachusetts General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00302406
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Methylphenidate
A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
Tetramethylphenylenediamine
Used in the form of the hydrochloride as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES.
Naphthylvinylpyridine
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Ambroxol
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
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