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Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder.

Abstract

OBJECTIVE

The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD).

METHOD

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with DSM-IV-defined ADHD. The study was carried out between 2001 and 2003. After a 2-week evaluation phase, patients were randomized to d-MPH-ER or placebo for 7 weeks. Flexible d-MPH-ER dosing (30 mg/day) was permitted for 5 weeks, then patients remained on their optimal dose during the last 2 study weeks. The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version (CADS-T) total subscale score. Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores, CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores, Clinical Global Impressions-Improvement (CGI-I) and CGI-Severity (CGI-S) scale scores, and Child Health Questionnaire Parent Form 50 scores.

RESULTS

d-MPH-ER improved CADS-T total scores significantly compared with placebo (p <.001), and 67.3% of d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3% of placebo patients (p <.001). More patients taking d-MPH-ER (49.1%) than placebo (25.5%) spontaneously reported adverse events suspected as drug related.

CONCLUSIONS

Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents.

Authors+Show Affiliations

Research Unit of Pediatric Psychopharmacology at the New York State Psychiatric Institute, New York, NY 10032, USA. llg2@columbia.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16832318

Citation

Greenhill, Laurence L., et al. "Efficacy and Safety of Dexmethylphenidate Extended-release Capsules in Children With Attention-deficit/hyperactivity Disorder." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 45, no. 7, 2006, pp. 817-23.
Greenhill LL, Muniz R, Ball RR, et al. Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(7):817-23.
Greenhill, L. L., Muniz, R., Ball, R. R., Levine, A., Pestreich, L., & Jiang, H. (2006). Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 45(7), pp. 817-23.
Greenhill LL, et al. Efficacy and Safety of Dexmethylphenidate Extended-release Capsules in Children With Attention-deficit/hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2006;45(7):817-23. PubMed PMID: 16832318.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. AU - Greenhill,Laurence L, AU - Muniz,Rafael, AU - Ball,Roberta R, AU - Levine,Alan, AU - Pestreich,Linda, AU - Jiang,Hai, PY - 2006/7/13/pubmed PY - 2007/6/27/medline PY - 2006/7/13/entrez SP - 817 EP - 23 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 45 IS - 7 N2 - OBJECTIVE: The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD). METHOD: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with DSM-IV-defined ADHD. The study was carried out between 2001 and 2003. After a 2-week evaluation phase, patients were randomized to d-MPH-ER or placebo for 7 weeks. Flexible d-MPH-ER dosing (30 mg/day) was permitted for 5 weeks, then patients remained on their optimal dose during the last 2 study weeks. The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version (CADS-T) total subscale score. Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores, CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores, Clinical Global Impressions-Improvement (CGI-I) and CGI-Severity (CGI-S) scale scores, and Child Health Questionnaire Parent Form 50 scores. RESULTS: d-MPH-ER improved CADS-T total scores significantly compared with placebo (p <.001), and 67.3% of d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3% of placebo patients (p <.001). More patients taking d-MPH-ER (49.1%) than placebo (25.5%) spontaneously reported adverse events suspected as drug related. CONCLUSIONS: Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents. SN - 0890-8567 UR - https://www.unboundmedicine.com/medline/citation/16832318/Efficacy_and_safety_of_dexmethylphenidate_extended_release_capsules_in_children_with_attention_deficit/hyperactivity_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)61528-8 DB - PRIME DP - Unbound Medicine ER -