BACKGROUND: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. METHODS: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. RESULTS: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (> or = 30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. CONCLUSIONS: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics.
RCT Entities:
BACKGROUND: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. METHODS: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. RESULTS: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (> or = 30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. CONCLUSIONS: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics.
Authors: Mary V Solanto; David J Marks; Jeanette Wasserstein; Katherine Mitchell; Howard Abikoff; Jose Ma J Alvir; Michele D Kofman Journal: Am J Psychiatry Date: 2010-03-15 Impact factor: 18.112
Authors: Geurt van de Glind; Katelijne Van Emmerik-van Oortmerssen; Pieter Jan Carpentier; Frances R Levin; Maarten W J Koeter; Csaba Barta; Sharlene Kaye; Arvid Skutle; Johan Franck; Maija Konstenius; Eli-Torild Bu; Franz Moggi; Geert Dom; Zolt Demetrovics; Mélina Fatséas; Arild Schillinger; Máté Kapitány-Fövény; Sofie Verspreet; Andrea Seitz; Brian Johnson; Stephen V Faraone; J Antoni Ramos-Quiroga; Steve Allsop; Susan Carruthers; Robert A Schoevers; Wim van den Brink Journal: Int J Methods Psychiatr Res Date: 2013-09-11 Impact factor: 4.035
Authors: Jan K Buitelaar; J Antoni Ramos-Quiroga; Miguel Casas; J J Sandra Kooij; Asko Niemelä; Eric Konofal; Joachim Dejonckheere; Bradford H Challis; Rossella Medori Journal: Neuropsychiatr Dis Treat Date: 2009-09-15 Impact factor: 2.570