{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:27:57Z","timestamp":1777879677052,"version":"3.51.4"},"reference-count":55,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2016,7,31]],"date-time":"2016-07-31T00:00:00Z","timestamp":1469923200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Psychopharmacology"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>\n                      Attention-deficit\/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child\u2019s development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA\n                      <jats:sup>\u00ae<\/jats:sup>\n                      to the same dose of generic Novo-methylphenidate ER-C\n                      <jats:sup>\u00ae<\/jats:sup>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2045125316643674","type":"journal-article","created":{"date-parts":[[2016,5,2]],"date-time":"2016-05-02T20:13:01Z","timestamp":1462219981000},"page":"237-251","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":14,"title":["A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA\n                    <sup>\u00ae<\/sup>\n                    ) and generic novo-methylphenidate ER-C (NOVO-generic)"],"prefix":"10.1177","volume":"6","author":[{"given":"Angelo","family":"Fallu","sequence":"first","affiliation":[{"name":"Clinique Woodward, 717, rue Woodward, DIEX Research Inc., Sherbrooke, QC, J1G 1W4, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farida","family":"Dabouz","sequence":"additional","affiliation":[{"name":"FB2D Clinical Research Consulting, Montr\u00e9al, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa","family":"Furtado","sequence":"additional","affiliation":[{"name":"START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leena","family":"Anand","sequence":"additional","affiliation":[{"name":"START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin A.","family":"Katzman","sequence":"additional","affiliation":[{"name":"START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada"},{"name":"The Northern Ontario School of Medicine, Thunder Bay, ON, Canada"},{"name":"Department of Psychology, Lakehead University, Thunder Bay, ON, Canada"},{"name":"University of Toronto, Toronto, ON, Canada"},{"name":"Adler Graduate Professional School, Toronto ON, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,7,31]]},"reference":[{"key":"bibr1-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/S0006-3223(03)00609-7"},{"key":"bibr2-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2005.00066.x"},{"key":"bibr3-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1097\/00004583-200403000-00006"},{"key":"bibr4-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2008.09.010"},{"key":"bibr5-2045125316643674","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v67n0403"},{"key":"bibr6-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ps.56.12.1617"},{"key":"bibr7-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(03)80157-1"},{"key":"bibr8-2045125316643674","first-page":"58","volume":"12","author":"Brod M.","year":"2005","journal-title":"Primary Psychiatry"},{"key":"bibr9-2045125316643674","volume-title":"Canadian ADHD Practice Guidelines","author":"Canadian ADHD Resource Alliance (CADDRA)","year":"2011","edition":"3"},{"key":"bibr10-2045125316643674","first-page":"24","volume":"5","author":"Cascade E.","year":"2008","journal-title":"Psychiatry (Edgmont)"},{"key":"bibr11-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1080\/10401230490281618"},{"key":"bibr12-2045125316643674","doi-asserted-by":"publisher","DOI":"10.3122\/jabfm.17.4.235"},{"key":"bibr13-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1136\/oem.2007.038448"},{"key":"bibr14-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-5949.2010.00210.x"},{"key":"bibr15-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1101\/lm.1092608"},{"key":"bibr16-2045125316643674","first-page":"321","volume":"29","author":"Endicott J.","year":"1993","journal-title":"Psychopharmacol Bull"},{"key":"bibr17-2045125316643674","first-page":"28","volume":"11","author":"Faraone S.","year":"2004","journal-title":"Primary Psychiatry"},{"key":"bibr18-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1097\/01.jcp.0000108984.11879.95"},{"key":"bibr19-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.106.034389"},{"key":"bibr20-2045125316643674","doi-asserted-by":"publisher","DOI":"10.4103\/0976-500X.120972"},{"key":"bibr21-2045125316643674","doi-asserted-by":"publisher","DOI":"10.3810\/pgm.2009.09.2049"},{"key":"bibr22-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1097\/00004583-200111000-00020"},{"key":"bibr23-2045125316643674","volume-title":"ECDEU Assessment Manual for Psychopharmacology","author":"Guy W.","year":"1976"},{"key":"bibr24-2045125316643674","unstructured":"Health Canada (2012a) Guidance document - Comparative bioavailability standards: Formulations used for systemic effects. 22 May 2012. Available at: http:\/\/www.hc-sc.gc.ca\/dhp-mps\/prodpharma\/applic-demande\/guide-ld\/bio\/gd_standards_ld_normes-eng.php (accessed 14 April 2015)."},{"key":"bibr25-2045125316643674","unstructured":"Health Canada (2012b) Guidance document - Conduct and analysis of comparative bioavailability studies. 22 May 2012. Available at: http:\/\/www.hc-sc.gc.ca\/dhp-mps\/prodpharma\/applic-demande\/guide-ld\/bio\/gd_cbs_ebc_ld-eng.php (accessed 14 April 2015)."},{"key":"bibr26-2045125316643674","unstructured":"Janssen Inc. (2011) Concerta (methylphenidate hydrochloride) Product Monograph. 5 December 2011. Available at: http:\/\/www.mun.ca\/pharmacy\/aboutpharmacy\/CONCERTA_PM_E.pdf (accessed 14 April 2015)."},{"key":"bibr27-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1176\/ajp.2006.163.4.716"},{"key":"bibr28-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1017\/S0033291704002892"},{"key":"bibr29-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpn.2006.10.002"},{"key":"bibr30-2045125316643674","first-page":"389","volume":"4","author":"Kolar D.","year":"2008","journal-title":"Neuropsychiatr Dis Treat"},{"key":"bibr31-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1177\/0269881113492030"},{"key":"bibr32-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-7610.2004.00221.x"},{"key":"bibr33-2045125316643674","first-page":"4","volume":"62","author":"Meyer M.","year":"2001","journal-title":"J Clin Psychiatry"},{"key":"bibr34-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1177\/0009922810394832"},{"key":"bibr35-2045125316643674","unstructured":"National Institute for Health and Care Excellence (NICE) (2008) NICE Clinical Guidelines: Attention deficit hyperactivity disorder: Diagnosis and Management of ADHD in children, young people and adults. London: NICE, p. 72."},{"key":"bibr36-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1017\/S1355617712000574"},{"key":"bibr37-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1093\/jpepsy\/jsm022"},{"key":"bibr38-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1176\/ajp.2007.164.6.942"},{"key":"bibr39-2045125316643674","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1177\/070674371105600101","volume":"56","author":"Ramasubbu R.","year":"2011","journal-title":"Can J Psychiatry"},{"key":"bibr40-2045125316643674","first-page":"109","volume":"57","author":"Rosenthal J.","year":"2008","journal-title":"J Fam Pract"},{"key":"bibr41-2045125316643674","volume-title":"The Anxiety Disease","author":"Sheehan D.","year":"1983"},{"key":"bibr42-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1002\/pst.1666"},{"key":"bibr43-2045125316643674","unstructured":"Stagnitti M. (2007) Trends in the use and expenditures for the Therapeutic Class Prescribed Psychotherapeutic agents and all Subclasses, 1997 and 2004. February 2007. Available at: http:\/\/www.meps.ahrq.gov\/mepsweb\/data_files\/publications\/st163\/stat163.pdf (accessed 14 April 2015)."},{"key":"bibr44-2045125316643674","volume-title":"Interventions for ADHD: Treatment in developmental context","author":"Teeter P.","year":"2000"},{"key":"bibr45-2045125316643674","unstructured":"US Food and Drug Administration (FDA) (2013) Update: Bupropion hydrochloride extended-release 300 mg bioequivalence studies. 10 October 2013. Available at: http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm322161.htm (accessed 14 April 2015)."},{"key":"bibr46-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1177\/0269881107077373"},{"key":"bibr47-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1093\/pch\/18.2.70"},{"key":"bibr48-2045125316643674","first-page":"811","volume":"146","author":"Vergouwen A.","year":"2002","journal-title":"Ned Tijdschr Geneeskd"},{"key":"bibr49-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2013.09.001"},{"key":"bibr50-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199206000-00002"},{"key":"bibr51-2045125316643674","doi-asserted-by":"crossref","first-page":"27","DOI":"10.4088\/JCP.v65n1020d","volume":"65","author":"Weiss M.","year":"2004","journal-title":"J Clin Psychiatry"},{"key":"bibr52-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1080\/09297040409609806"},{"key":"bibr53-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2010.0047"},{"key":"bibr54-2045125316643674","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1684\/epd.2009.0278","volume":"11","author":"Yoo H.","year":"2009","journal-title":"Epileptic Disord"},{"key":"bibr55-2045125316643674","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-0327(03)00160-5"}],"container-title":["Therapeutic Advances in Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2045125316643674","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2045125316643674","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2045125316643674","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:50:30Z","timestamp":1777593030000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2045125316643674"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,7,31]]},"references-count":55,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2016,8]]}},"alternative-id":["10.1177\/2045125316643674"],"URL":"https:\/\/doi.org\/10.1177\/2045125316643674","relation":{},"ISSN":["2045-1253","2045-1261"],"issn-type":[{"value":"2045-1253","type":"print"},{"value":"2045-1261","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,7,31]]}}}