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A randomized, placebo-controlled trial of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder.
Biol Psychiatry 2006; 59(9):829-35BP

Abstract

BACKGROUND

The objective of this study was to evaluate the safety and efficacy of once-daily OROS methylphenidate (MPH) in the treatment of adults with DSM-IV attention-deficit/hyperactivity disorder (ADHD).

METHODS

We conducted a randomized, 6-week, placebo-controlled, parallel-design study of OROS MPH in 141 adult subjects with DSM-IV ADHD, using standardized instruments for diagnosis. OROS MPH or placebo was initiated at 36 mg/day and titrated to optimal response, depending on efficacy and tolerability, up to 1.3 mg/kg/day.

RESULTS

Treatment with OROS MPH was associated with clinically and statistically significant reductions in DSM-IV symptoms of inattention and hyperactivity/impulsivity relative to subjects treated with placebo. At endpoint, 66% of subjects (n = 44) receiving OROS MPH and 39% of subjects (n = 29) [corrected] receiving placebo attained our a priori definition of response of much or very much improved on the Clinical Global Impression-Improvement scale plus a >30% reduction in Adult ADHD Investigator System Report Scale score. OROS MPH was associated with small but statistically significant increases in systolic blood pressure (3.5 +/- 11.8 mm Hg), diastolic blood pressure (4.0 +/- 8.5 mm Hg), and heart rate (4.5 +/- 10.5 bpm).

CONCLUSIONS

These results show that treatment with OROS MPH in daily doses of up to 1.3 mg/kg/day was effective in the treatment of adults with ADHD. Because of the potential for increases in blood pressure and heart rate, subjects receiving treatment with MPH should be monitored for changes in blood pressure parameters during treatment.

Authors+Show Affiliations

Clinical and Research Program in Pediatric Psychopharmacology at the Massachusetts General Hospital, Boston, Massachusetts, USA. jbiederman@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16373066

Citation

Biederman, Joseph, et al. "A Randomized, Placebo-controlled Trial of OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder." Biological Psychiatry, vol. 59, no. 9, 2006, pp. 829-35.
Biederman J, Mick E, Surman C, et al. A randomized, placebo-controlled trial of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2006;59(9):829-35.
Biederman, J., Mick, E., Surman, C., Doyle, R., Hammerness, P., Harpold, T., ... Spencer, T. (2006). A randomized, placebo-controlled trial of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biological Psychiatry, 59(9), pp. 829-35.
Biederman J, et al. A Randomized, Placebo-controlled Trial of OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder. Biol Psychiatry. 2006 May 1;59(9):829-35. PubMed PMID: 16373066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled trial of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. AU - Biederman,Joseph, AU - Mick,Eric, AU - Surman,Craig, AU - Doyle,Robert, AU - Hammerness,Paul, AU - Harpold,Theresa, AU - Dunkel,Stephanie, AU - Dougherty,Meghan, AU - Aleardi,Megan, AU - Spencer,Thomas, Y1 - 2005/12/20/ PY - 2005/04/08/received PY - 2005/08/11/revised PY - 2005/09/16/accepted PY - 2005/12/24/pubmed PY - 2006/6/29/medline PY - 2005/12/24/entrez SP - 829 EP - 35 JF - Biological psychiatry JO - Biol. Psychiatry VL - 59 IS - 9 N2 - BACKGROUND: The objective of this study was to evaluate the safety and efficacy of once-daily OROS methylphenidate (MPH) in the treatment of adults with DSM-IV attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted a randomized, 6-week, placebo-controlled, parallel-design study of OROS MPH in 141 adult subjects with DSM-IV ADHD, using standardized instruments for diagnosis. OROS MPH or placebo was initiated at 36 mg/day and titrated to optimal response, depending on efficacy and tolerability, up to 1.3 mg/kg/day. RESULTS: Treatment with OROS MPH was associated with clinically and statistically significant reductions in DSM-IV symptoms of inattention and hyperactivity/impulsivity relative to subjects treated with placebo. At endpoint, 66% of subjects (n = 44) receiving OROS MPH and 39% of subjects (n = 29) [corrected] receiving placebo attained our a priori definition of response of much or very much improved on the Clinical Global Impression-Improvement scale plus a >30% reduction in Adult ADHD Investigator System Report Scale score. OROS MPH was associated with small but statistically significant increases in systolic blood pressure (3.5 +/- 11.8 mm Hg), diastolic blood pressure (4.0 +/- 8.5 mm Hg), and heart rate (4.5 +/- 10.5 bpm). CONCLUSIONS: These results show that treatment with OROS MPH in daily doses of up to 1.3 mg/kg/day was effective in the treatment of adults with ADHD. Because of the potential for increases in blood pressure and heart rate, subjects receiving treatment with MPH should be monitored for changes in blood pressure parameters during treatment. SN - 0006-3223 UR - https://www.unboundmedicine.com/medline/citation/16373066/A_randomized_placebo_controlled_trial_of_OROS_methylphenidate_in_adults_with_attention_deficit/hyperactivity_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0006-3223(05)01207-2 DB - PRIME DP - Unbound Medicine ER -