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A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan.
World J Biol Psychiatry 2014; 15(6):488-98WJ

Abstract

OBJECTIVES

To evaluate the safety and efficacy of osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) HCl in adults with attention-deficit/hyperactivity disorder (ADHD).

METHODS

In this study, 284 adults with ADHD were randomized to OROS MPH or placebo. During the 4-week titration period, patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments. Patients continued on their individualized dose during the 4-week efficacy assessment period. The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O:SV) from baseline to endpoint.

RESULTS

The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O:SV was significantly larger with OROS MPH compared with placebo (P < 0.0001, ANCOVA). Similar results were observed for the majority of secondary endpoints, including CAARS-O:SV total score and other subscale scores. Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81.8%) versus the placebo group (53.9%), OROS-MPH showed a well-tolerated safety profile overall.

CONCLUSIONS

OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD.

Authors+Show Affiliations

Clinical Responsible Physician Department, Clinical Science Division , Janssen Pharmaceutical K.K, Tokyo , Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24456065

Citation

Takahashi, Nagahide, et al. "A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Osmotic-controlled Release Oral Delivery System Methylphenidate HCl in Adults With Attention-deficit/hyperactivity Disorder in Japan." The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry, vol. 15, no. 6, 2014, pp. 488-98.
Takahashi N, Koh T, Tominaga Y, et al. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan. World J Biol Psychiatry. 2014;15(6):488-98.
Takahashi, N., Koh, T., Tominaga, Y., Saito, Y., Kashimoto, Y., & Matsumura, T. (2014). A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan. The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry, 15(6), pp. 488-98. doi:10.3109/15622975.2013.868925.
Takahashi N, et al. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Osmotic-controlled Release Oral Delivery System Methylphenidate HCl in Adults With Attention-deficit/hyperactivity Disorder in Japan. World J Biol Psychiatry. 2014;15(6):488-98. PubMed PMID: 24456065.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan. AU - Takahashi,Nagahide, AU - Koh,Tadaishi, AU - Tominaga,Yushin, AU - Saito,Yuki, AU - Kashimoto,Yuji, AU - Matsumura,Taka, Y1 - 2014/01/23/ PY - 2014/1/25/entrez PY - 2014/1/25/pubmed PY - 2015/5/13/medline KW - Japan KW - adult KW - attention deficit disorder with hyperactivity KW - methylphenidate KW - randomized controlled trial SP - 488 EP - 98 JF - The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry JO - World J. Biol. Psychiatry VL - 15 IS - 6 N2 - OBJECTIVES: To evaluate the safety and efficacy of osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) HCl in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: In this study, 284 adults with ADHD were randomized to OROS MPH or placebo. During the 4-week titration period, patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments. Patients continued on their individualized dose during the 4-week efficacy assessment period. The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O:SV) from baseline to endpoint. RESULTS: The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O:SV was significantly larger with OROS MPH compared with placebo (P < 0.0001, ANCOVA). Similar results were observed for the majority of secondary endpoints, including CAARS-O:SV total score and other subscale scores. Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81.8%) versus the placebo group (53.9%), OROS-MPH showed a well-tolerated safety profile overall. CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD. SN - 1814-1412 UR - https://www.unboundmedicine.com/medline/citation/24456065/A_randomized_double_blind_placebo_controlled_parallel_group_study_to_evaluate_the_efficacy_and_safety_of_osmotic_controlled_release_oral_delivery_system_methylphenidate_HCl_in_adults_with_attention_deficit/hyperactivity_disorder_in_Japan_ L2 - http://www.tandfonline.com/doi/full/10.3109/15622975.2013.868925 DB - PRIME DP - Unbound Medicine ER -