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Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.
Arch Pediatr Adolesc Med. 2006 Jan; 160(1):82-90.AP

Abstract

BACKGROUND

Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group.

OBJECTIVE

To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate.

DESIGN

Adolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD.

RESULTS

A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups.

CONCLUSION

In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.

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Authors+Show Affiliations

Wilens TE
Pediatric Psychopharmacology Unit, Massachusetts General Hospital, YAW-6-6A, 32 Fruit Street, Boston, MA 02114, USA. twilens@partners.org
McBurnett K
No affiliation info available
Bukstein O
No affiliation info available
McGough J
No affiliation info available
Greenhill L
No affiliation info available
Lerner M
No affiliation info available
Stein MA
No affiliation info available
Conners CK
No affiliation info available
Duby J
No affiliation info available
Newcorn J
No affiliation info available
Bailey CE
No affiliation info available
Kratochvil CJ
No affiliation info available
Coury D
No affiliation info available
Casat C
No affiliation info available
Denisco MJ
No affiliation info available
Halstead P
No affiliation info available
Bloom L
No affiliation info available
Zimmerman BA
No affiliation info available
Gu J
No affiliation info available
Cooper KM
No affiliation info available
Lynch JM
No affiliation info available

MeSH

Administration, OralAdolescentAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMethylphenidateOsmosisTreatment Outcome

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16389216

Clinical Trial Links

An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

Citation

Wilens, Timothy E., et al. "Multisite Controlled Study of OROS Methylphenidate in the Treatment of Adolescents With Attention-deficit/hyperactivity Disorder." Archives of Pediatrics & Adolescent Medicine, vol. 160, no. 1, 2006, pp. 82-90.
Wilens TE, McBurnett K, Bukstein O, et al. Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med. 2006;160(1):82-90.
Wilens, T. E., McBurnett, K., Bukstein, O., McGough, J., Greenhill, L., Lerner, M., Stein, M. A., Conners, C. K., Duby, J., Newcorn, J., Bailey, C. E., Kratochvil, C. J., Coury, D., Casat, C., Denisco, M. J., Halstead, P., Bloom, L., Zimmerman, B. A., Gu, J., ... Lynch, J. M. (2006). Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Archives of Pediatrics & Adolescent Medicine, 160(1), 82-90.
Wilens TE, et al. Multisite Controlled Study of OROS Methylphenidate in the Treatment of Adolescents With Attention-deficit/hyperactivity Disorder. Arch Pediatr Adolesc Med. 2006;160(1):82-90. PubMed PMID: 16389216.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. AU - Wilens,Timothy E, AU - McBurnett,Keith, AU - Bukstein,Oscar, AU - McGough,James, AU - Greenhill,Laurence, AU - Lerner,Marc, AU - Stein,Mark A, AU - Conners,C Keith, AU - Duby,John, AU - Newcorn,Jeffrey, AU - Bailey,Charles E, AU - Kratochvil,Christopher J, AU - Coury,Daniel, AU - Casat,Charles, AU - Denisco,Mary Joan C, AU - Halstead,Patricia, AU - Bloom,Leslie, AU - Zimmerman,Brenda A, AU - Gu,Joan, AU - Cooper,Kimberly M, AU - Lynch,Joseph M, PY - 2006/1/4/pubmed PY - 2006/1/27/medline PY - 2006/1/4/entrez SP - 82 EP - 90 JF - Archives of pediatrics & adolescent medicine JO - Arch Pediatr Adolesc Med VL - 160 IS - 1 N2 - BACKGROUND: Despite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group. OBJECTIVE: To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate. DESIGN: Adolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD. RESULTS: A significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups. CONCLUSION: In adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d. SN - 1072-4710 UR - https://www.unboundmedicine.com/medline/citation/16389216/Multisite_controlled_study_of_OROS_methylphenidate_in_the_treatment_of_adolescents_with_attention_deficit/hyperactivity_disorder_ L2 - https://jamanetwork.com/journals/jamapediatrics/fullarticle/10.1001/archpedi.160.1.82 DB - PRIME DP - Unbound Medicine ER -
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