Randomized, Controlled Trial of OROS Methylphenidate Once a Day in Children With Attention-Deficit/Hyperactivity Disorder

American Academy of Pediatrics (AAP) - Tập 108 Số 4 - Trang 883-892 - 2001
Mark L. Wolraich1, Laurence L. Greenhill2,3, William E. Pelham4, James M. Swanson5, Timothy E. Wilens6,7, Donna Palumbo8, Marc S. Atkins9, Keith McBurnett10, Oscar G. Bukstein11, Gerald J. August12,13
1Vanderbilt University, Nashville, Tennessee, USA
2Columbia University
3New York State Psychiatric Institute, New York
4State University of New York at Buffalo, Buffalo, New York
5University of California at Irvine, Irvine, California
6Harvard University
7Massachusetts General Hospital, Boston, Massachusetts
8University of Rochester, Rochester, Minnesota;
9University of Illinois at Chicago, Chicago, Illinois
10University of Chicago, Chicago, Illinois
11Western Psychiatric Institute and Clinic, University of Pittsburgh, Pittsburgh, Pennsylvania; and
12Family Social Science
13University of Minnesota, Rochester, Minnesota.

Tóm tắt

Objective. A new once-a-day methylphenidate (MPH) formulation, Concerta (methylphenidate HCl) extended-release tablets (OROS MPH), has been developed. This study was conducted to determine the safety and efficacy of OROS MPH in a multicenter, randomized, clinical trial. Methods. Children with attention-deficit/hyperactivity disorder (ADHD; n = 282), all subtypes, ages 6 to 12 years, were randomized to placebo (n = 90), immediate-release methylphenidate (IR MPH) 3 times a day (tid; dosed every 4 hours; n = 97), or OROS MPH once a day (qd;n = 95) in a double-blind, 28-day trial. Outcomes in multiple domains were assessed, and data were analyzed using analysis of variance and Kaplan Meier product limit estimates for time to study cessation. The primary time point for analysis was the last available patient visit using last observation carried forward. Results. Children in the OROS and IR MPH groups showed significantly greater reductions in core ADHD symptoms than did children on placebo. This was true both at the end of week 1 and at the end of treatment on the basis of mean teacher and parent IOWA Conners ratings. IR MPH tid and OROS MPH qd did not differ significantly on any direct comparisons. Forty-eight percent of the placebo group discontinued early compared with 14% and 16% in the IR MPH and OROS MPH groups, respectively. Conclusions. For the treatment of core ADHD symptoms, OROS MPH dosed qd and IR MPH dosed tid were superior to placebo and were not significantly different from each other.attention-deficit/hyperactivity disorder, methylphenidate, OROS, Concerta.

Từ khóa


Tài liệu tham khảo

Greenhill, 1995, Attention-deficit hyperactivity disorder: the stimulants., Child Adolesc Psychiatr Clin North Am, 4, 123, 10.1016/S1056-4993(18)30455-3

Shaffer, 1996, The NIMH Diagnostic Interview Schedule for Children Version 2.3 (DISC-2.3): description, acceptability, prevalence rates, and performance in the MECA study., J Am Acad Child Adolesc Psychiatry, 35, 865, 10.1097/00004583-199607000-00012

Shaffer, 1983, A children's global assessment scale (CGAS)., Arch Gen Psychiatry, 40, 1228, 10.1001/archpsyc.1983.01790100074010

Swanson, 2000, Initiating Concerta (OROS methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder., J Clin Res, 3, 59

Atkins, 1989, The differential validity of teacher ratings of inattention/overactivity and aggression., J Abnorm Child Psychol, 17, 423, 10.1007/BF00915036

MTA Cooperative Group, 1999, 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder., Arch Gen Psychiatry, 56, 1073, 10.1001/archpsyc.56.12.1073

Connors, 1985, Clinical Global Impression Scale (CGI)., Psychopharmacol Bull, 21, 809

Emslie, 1997, A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression., Arch Gen Psychiatry, 54, 1031, 10.1001/archpsyc.1997.01830230069010

Modi, 2000, Single and multiple-dose pharmacokinetics of an oral once-a-day osmotic controlled release OROS (methylphenidate HCl) formulation., J Clin Pharmacol, 40, 379, 10.1177/00912700022009080

Swanson, 2001, Clinical relevance of the primary findings of the MTA: success rates based on severity of symptoms at the end of treatment., J Am Acad Child Adolesc Psychiatry, 40, 168, 10.1097/00004583-200102000-00011

Barkley, 1990, Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation., Pediatrics, 86, 184, 10.1542/peds.86.2.184

Ahmann, 1993, Placebo-controlled evaluation of Ritalin side effects., Pediatrics, 91, 1101, 10.1542/peds.91.6.1101

Thông tin
Thông tin xuất bản

American Academy of Pediatrics (AAP)

Tập 108 Số 4

883-892

Thông tin tác giả