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Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study.
J Clin Psychopharmacol 2009; 29(3):239-47JC

Abstract

OBJECTIVE

To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the management of attention-deficit/hyperactivity disorder (ADHD) in adults.

METHODS

A randomized, 7-week, double-blind, placebo-controlled, dose-escalation, parallel-group study of OROS methylphenidate 36, 54, 72, 90, or 108 mg/d versus placebo was conducted in adults with ADHD. The primary end point was the Adult ADHD Investigator Symptom Report Scale. Other assessments included the Clinical Global Impressions-Improvement scale, a post hoc responder analysis, adverse events, and vital signs.

RESULTS

Two hundred twenty-six subjects (56.2% male; mean age, 39.0 years; range, 18-65 years) were included in the intention-to-treat population (110 subjects on OROS methylphenidate; 116 subjects on placebo). OROS methylphenidate resulted in greater ADHD symptom improvement than placebo as demonstrated by a statistically significantly lower least squares mean change from baseline in Adult ADHD Investigator Symptom Report Scale total score at the final visit (last observation carried forward [LOCF]; P = 0.012). Subjects on OROS methylphenidate also had a significantly lower least squares mean Clinical Global Impressions-Improvement score at the final visit (LOCF; P = 0.008). A significantly greater proportion of subjects on OROS methylphenidate (36.9%, 38/103 subjects) were responders at the final visit (LOCF) compared with placebo (20.9%, 24/115 subjects; P = 0.009). OROS methylphenidate was well tolerated. Adverse events were reported by 93 (84.5%) of the 110 OROS methylphenidate-treated subjects versus 74 (63.8%) of the 116 placebo-treated subjects. No serious treatment-emergent adverse events and no deaths were reported. Similar mean changes from baseline to final visit (LOCF) for systolic and diastolic blood pressures for the OROS methylphenidate and placebo groups were observed.

CONCLUSIONS

In a dose escalation ranging from 36 to 108 mg/d, OROS methylphenidate is effective and well tolerated in the management of ADHD in adults.

Authors+Show Affiliations

NYU School of Medicine, New York VA Harbor Healthcare System, New York, NY 10016, USA. lenard.adler@med.nyu.eduNo affiliation info availableNo 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

19440077

Citation

Adler, Lenard A., et al. "Efficacy and Safety of OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder: a Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-escalation Study." Journal of Clinical Psychopharmacology, vol. 29, no. 3, 2009, pp. 239-47.
Adler LA, Zimmerman B, Starr HL, et al. Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. J Clin Psychopharmacol. 2009;29(3):239-47.
Adler, L. A., Zimmerman, B., Starr, H. L., Silber, S., Palumbo, J., Orman, C., & Spencer, T. (2009). Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. Journal of Clinical Psychopharmacology, 29(3), pp. 239-47. doi:10.1097/JCP.0b013e3181a390ce.
Adler LA, et al. Efficacy and Safety of OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder: a Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-escalation Study. J Clin Psychopharmacol. 2009;29(3):239-47. PubMed PMID: 19440077.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. AU - Adler,Lenard A, AU - Zimmerman,Brenda, AU - Starr,H Lynn, AU - Silber,Steve, AU - Palumbo,Joseph, AU - Orman,Camille, AU - Spencer,Thomas, PY - 2009/5/15/entrez PY - 2009/5/15/pubmed PY - 2009/8/4/medline SP - 239 EP - 47 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 29 IS - 3 N2 - OBJECTIVE: To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the management of attention-deficit/hyperactivity disorder (ADHD) in adults. METHODS: A randomized, 7-week, double-blind, placebo-controlled, dose-escalation, parallel-group study of OROS methylphenidate 36, 54, 72, 90, or 108 mg/d versus placebo was conducted in adults with ADHD. The primary end point was the Adult ADHD Investigator Symptom Report Scale. Other assessments included the Clinical Global Impressions-Improvement scale, a post hoc responder analysis, adverse events, and vital signs. RESULTS: Two hundred twenty-six subjects (56.2% male; mean age, 39.0 years; range, 18-65 years) were included in the intention-to-treat population (110 subjects on OROS methylphenidate; 116 subjects on placebo). OROS methylphenidate resulted in greater ADHD symptom improvement than placebo as demonstrated by a statistically significantly lower least squares mean change from baseline in Adult ADHD Investigator Symptom Report Scale total score at the final visit (last observation carried forward [LOCF]; P = 0.012). Subjects on OROS methylphenidate also had a significantly lower least squares mean Clinical Global Impressions-Improvement score at the final visit (LOCF; P = 0.008). A significantly greater proportion of subjects on OROS methylphenidate (36.9%, 38/103 subjects) were responders at the final visit (LOCF) compared with placebo (20.9%, 24/115 subjects; P = 0.009). OROS methylphenidate was well tolerated. Adverse events were reported by 93 (84.5%) of the 110 OROS methylphenidate-treated subjects versus 74 (63.8%) of the 116 placebo-treated subjects. No serious treatment-emergent adverse events and no deaths were reported. Similar mean changes from baseline to final visit (LOCF) for systolic and diastolic blood pressures for the OROS methylphenidate and placebo groups were observed. CONCLUSIONS: In a dose escalation ranging from 36 to 108 mg/d, OROS methylphenidate is effective and well tolerated in the management of ADHD in adults. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/19440077/Efficacy_and_safety_of_OROS_methylphenidate_in_adults_with_attention_deficit/hyperactivity_disorder:_a_randomized_placebo_controlled_double_blind_parallel_group_dose_escalation_study_ L2 - http://Insights.ovid.com/pubmed?pmid=19440077 DB - PRIME DP - Unbound Medicine ER -