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A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder.
Biol Psychiatry 2008; 63(10):981-9BP

Abstract

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+Show Affiliations

Janssen-Cilag EMEA, Neuss, Germany. rmedori@jacde.jnj.comNo 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

18206857

Citation

Medori, Rossella, et al. "A Randomized, Placebo-controlled Trial of Three Fixed Dosages of Prolonged-release OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder." Biological Psychiatry, vol. 63, no. 10, 2008, pp. 981-9.
Medori R, Ramos-Quiroga JA, Casas M, et al. A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008;63(10):981-9.
Medori, R., Ramos-Quiroga, J. A., Casas, M., Kooij, J. J., Niemelä, A., Trott, G. E., ... Buitelaar, J. K. (2008). A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biological Psychiatry, 63(10), pp. 981-9. doi:10.1016/j.biopsych.2007.11.008.
Medori R, et al. A Randomized, Placebo-controlled Trial of Three Fixed Dosages of Prolonged-release OROS Methylphenidate in Adults With Attention-deficit/hyperactivity Disorder. Biol Psychiatry. 2008 May 15;63(10):981-9. PubMed PMID: 18206857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. AU - Medori,Rossella, AU - Ramos-Quiroga,J Antoni, AU - Casas,Miguel, AU - Kooij,J J S, AU - Niemelä,Asko, AU - Trott,Götz-Erik, AU - Lee,Emma, AU - Buitelaar,Jan K, Y1 - 2008/01/22/ PY - 2007/07/30/received PY - 2007/11/02/revised PY - 2007/11/03/accepted PY - 2008/1/22/pubmed PY - 2008/7/12/medline PY - 2008/1/22/entrez SP - 981 EP - 9 JF - Biological psychiatry JO - Biol. Psychiatry VL - 63 IS - 10 N2 - 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. SN - 1873-2402 UR - https://www.unboundmedicine.com/medline/citation/18206857/A_randomized_placebo_controlled_trial_of_three_fixed_dosages_of_prolonged_release_OROS_methylphenidate_in_adults_with_attention_deficit/hyperactivity_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0006-3223(07)01102-X DB - PRIME DP - Unbound Medicine ER -