A randomized, 3-phase, 34-week, double-blind, long-term efficacy study of
osmotic-release oral system-methylphenidate in adults with
attention-deficit/hyperactivity disorder.
Author(s): Biederman J, Mick E, Surman C, Doyle R, Hammerness P, Kotarski M, Spencer T.
Affiliation(s): Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts
General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
Publication date & source: 2010, J Clin Psychopharmacol. , 30(5):549-53
We conducted a 3-phase, double-blind, placebo-controlled, parallel study design
of osmotic-release oral system (OROS)-methylphenidate (MPH) in adults (19-60
years of age) with attention deficit/hyperactivity disorder as classified by the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Phase 1 of
the study was a 6-week, acute efficacy trial (n = 223), phase 2 was a 24-week,
double-blind continuation study of responders (n = 96), and phase 3 was a
double-blind, placebo-controlled, 4-week discontinuation study (n = 23). The mean
daily dosage at phase 1 endpoint was 78.4 ± 31.7 mg (0.97 ± 0.32 mg/kg) OROS-MPH
and 96.6 ± 26.5 mg (1.16 ± 0.19 mg/kg) placebo (P < 0.0001). Clinical response at
phase 1 endpoint was significantly greater in the OROS-MPH group (62%, n = 67 vs
37%, n = 41; P < 0.001) and was maintained throughout 24 weeks of double-blind
treatment. With double-blind, placebo-controlled discontinuation, however, there
was no statistically significant difference in the rate of relapse between
OROS-MPH responders randomized to placebo and those randomized to continue active
treatment (18%, n = 2 vs 0%, n = 0; P = 0.1). As expected, decreased appetite,
insomnia, being tense/jittery, mucosal dryness, and neurological symptoms were
statistically significantly associated with OROS-MPH treatment. More work is
needed to be conducted with larger samples being followed to study completion to
better understand the long-lasting impact of pharmacotherapy for adult
attention-deficit/hyperactivity disorder.
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