Journal Article

Dose Effects and Comparative Effectiveness of Extended Release Dexmethylphenidate and Mixed Amphetamine Salts

Charney, Elizabeth, Gruber, Reut, Newcorn, Jeffrey H., Waldman, Irwin D., Aryal, Subhash, Sable, Craig, Stein, Mark A.

2011

Overview

Objective: To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity disorder (ADHD) symptom dimensions, global and specific impairments, and common adverse events associated with stimulants. Methods: Fifty-six children and adolescents with ADHD participated in an 8-week, double-blind, crossover study comparing ER d-MPH (10, 20, 25–30 mg) and ER MAS (10, 20, 25–30) with a week of randomized placebo within each drug period. Efficacy was assessed with the ADHD Rating Scale-IV (ADHD-RS-IV), whereas global and specific domains of impairment were assessed with the Clinical Global Impressions Severity and Improvement Scales and the parent-completed Weiss Functional Impairment Scale, respectively. Insomnia and decreased appetite, common stimulant-related adverse events, were measured with the parent-completed Stimulant Side Effects Rating Scale. Results: Both ER d-MPH and ER MAS were associated with significant reductions in ADHD symptoms. Improvement in Total ADHD and Hyperactivity/Impulsivity symptoms were strongly associated with increasing dose, whereas improvements in Inattentive symptoms were only moderately associated with dose. About 80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ER MAS compared with 79% when receiving ER d-MPH. Decreased appetite and insomnia were more common at higher dose levels for both stimulants. Approximately 43% of the responders were preferential responders to only one of the stimulant formulations. Conclusions: Dose level, rather than stimulant class, was strongly related to medication response.

• Publisher: SAGE Publications,Mary Ann Liebert, Inc
• Subject: Adolescent / Amphetamines / Amphetamines - administration & dosage / Amphetamines - adverse effects / Amphetamines - therapeutic use / Appetite - drug effects / Attention Deficit Disorder with Hyperactivity - drug therapy / Attention deficit hyperactivity disorder / Central Nervous System Stimulants - administration & dosage / Central Nervous System Stimulants - adverse effects / Central Nervous System Stimulants - therapeutic use / Child / Child & adolescent psychiatry / Cross-Over Studies / Delayed-Action Preparations - adverse effects / Delayed-Action Preparations - therapeutic use / Dexmethylphenidate Hydrochloride / Dose-Response Relationship, Drug / Double-Blind Method / Drug therapy / Female / Humans / Male / Methylphenidate - administration & dosage / Methylphenidate - adverse effects / Methylphenidate - therapeutic use / Original / Psychiatric Status Rating Scales - statistics & numerical data / Psychopharmacology / Side effects / Sleep Initiation and Maintenance Disorders - chemically induced