Cited by 186Attention Deficit Hyperactivity DisorderSchizophrenia research and treatmentPharmaceutical studies and practices

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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

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Medori, Rossella, Ramos-Quiroga, J. Antoni, Casas, Miguel, Kooij, J.J.S., Niemelä, Asko, Trott, Götz-Erik, Lee, Emma, Buitelaar, Jan K.·2008·Biological Psychiatry

DOI 10.1016/j.biopsych.2007.11.008

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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.

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Rostain, A. L. (2008) · Postgraduate Medicine · doi:10.3810/pgm.2008.09.1905 · Cited by 50
Criterion and concurrent validity of Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID) Spanish version.
Ramos-Quiroga, J., Bosch, R., Richarte, V., Valero, S., Gómez-Barros, N., Nogueira, M., Palomar, G., Corrales, M., Sáez-Francàs, N., Corominas, M., et al. (2012) · Revista de Psiquiatría y Salud Mental · doi:10.1016/j.rpsm.2012.05.004 · Cited by 39
Self-citation
Pharmacotherapy of ADHD in Adults
Wilens, T. E. (2008) · CNS Spectrums · doi:10.1017/s1092852900002960 · Cited by 50
A randomized comparison of long acting methylphenidate and cognitive behavioral therapy in the treatment of binge eating disorder
Quilty, L. C., Allen, T. A., Davis, C. A., Knyahnytska, Y., & Kaplan, A. S. (2019) · Psychiatry Research · doi:10.1016/j.psychres.2019.01.066 · Cited by 53
Amphetamines for Attention Deficit Hyperactivity Disorder (ADHD) in adults
Castells, X., Ramos-Quiroga, J. A., Bosch, R., Nogueira, M., & Casas, M. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007813.pub2 · Cited by 80
Self-citation
Long-Term Safety of OROS Methylphenidate in Adults With Attention-Deficit/Hyperactivity Disorder: An Open-Label, Dose-Titration, 1-Year Study
Adler, L. A., Orman, C., Starr, H., Silber, S., Palumbo, J., Cooper, K., Berwaerts, J., & Harrison, D. (2011) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e318203ea0a · Cited by 48
“Future studies should also allow the dose to be initiated at 18 mg and reduced to 18 mg for subjects who exhibit adverse events at 36 mg, as 18 mg has been shown to be effective in a fixed-dose placebocontrolled study.(13) There were other limitations with the current study.”
BackgroundResult
Recognizing ADHD in Adults with Comorbid Mood Disorders: Implications for Identification and Management
Goodman, D. W., & Thase, M. E. (2009) · Postgraduate Medicine · doi:10.3810/pgm.2009.09.2049 · Cited by 47
Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial
Kooij, J. J. S., Rösler, M., Philipsen, A., Wächter, S., Dejonckheere, J., van der Kolk, A., van Agthoven, M., & Schäuble, B. (2013) · BMC Psychiatry · doi:10.1186/1471-244x-13-36 · Cited by 44
Self-citation
Long-acting stimulants for treatment of attention-deficit/hyperactivity disorder: a focus on extended-release formulations and the prodrug lisdexamfetamine dimesylate to address continuing clinical challenges
López, F. A., & Leroux, J. R. (2013) · ADHD Attention Deficit and Hyperactivity Disorders · doi:10.1007/s12402-013-0106-x · Cited by 43
“Similar improvements compared with placebo in the symptoms of ADHD have been described in adults treated with OROS-MPH (Adler et al. 2009; Biederman et al. 2006b; Medori et al. 2008).”
Result
Driving performance in adults with ADHD: Results from a randomized, waiting list controlled trial with atomoxetine
Sobanski, E., Sabljic, D., Alm, B., Dittmann, R., Wehmeier, P. M., Skopp, G., & Strohbeck-Kühner, P. (2012) · European Psychiatry · doi:10.1016/j.eurpsy.2012.08.001 · Cited by 42
“Treatment response to ATX was defined as a greater or equal to 30% reduction of the CAARS-O:L total DSM-IV ADHD score, which is in accordance to other intervention studies [26].”
Result
A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
Arnold, V. K., Feifel, D., Earl, C. Q., Yang, R., & Adler, L. A. (2014) · Journal of Attention Disorders · doi:10.1177/1087054712441969 · Cited by 48
“In contrast to the above studies, the overall withdrawal rate in a study of methylphenidate in adult ADHD was 9% (Medori et al., 2008), and the withdrawal rate in two 10-week studies of the nonstimulant atomoxetine in adult ADHD was 24% (Michelson et al., 2003).”
Result
Stimulant Drug Effects on Attention Deficit/Hyperactivity Disorder: A Review of the Effects of Age and Sex of Patients
Cornforth, C., Sonuga-Barke, E., & Coghill, D. (2010) · Current Pharmaceutical Design · doi:10.2174/138161210791959827 · Cited by 41
“There are now several published RCTs which describe the fficacy of MPH in adult patients [95, 116-122].”
Background
Database analysis of children and adolescents with Bipolar Disorder consuming a micronutrient formula
Rucklidge, J. J., Gately, D., & Kaplan, B. J. (2010) · BMC Psychiatry · doi:10.1186/1471-244x-10-74 · Cited by 41
“Further, although it appears that the ADHD symptoms in those with both ADHD and PBD did not improve as much as those with ADHD-only (55% versus 76% if one takes 30% reduction as a good indicator of improvement in ADHD symptoms [44]), the ADHDonly sample showed a higher baseline value; the LOCF values were comparable.”
BackgroundResult
Efficacy, Acceptability, and Tolerability of Lisdexamfetamine, Mixed Amphetamine Salts, Methylphenidate, and Modafinil in the Treatment of Attention-Deficit Hyperactivity Disorder in Adults: A Systematic Review and Meta-analysis
Stuhec, M., Lukić, P., & Locatelli, I. (2019) · Annals of Pharmacotherapy · doi:10.1177/1060028018795703 · Cited by 46
“The studies were split into 3 subgroups according to the release form—namely, immediate release,(34,38) extended release,(33,36,37,39) and osmotic controlled oral delivery system.(28-32,35,40,41) No dissimilarity in efficacy was observed between different release forms of MPH.”
Background
A Review of OROS Methylphenidate (Concerta®) in the Treatment of Attention-Deficit/Hyperactivity Disorder
Katzman, M. A., & Sternat, T. (2014) · CNS Drugs · doi:10.1007/s40263-014-0175-1 · Cited by 40
“OROS MPH has been studied in adults with ADHD at doses ranging from 36 to 108 mg/day [85, 89, 94].”
BackgroundMethod
Delivering Evidence-Based Treatments for Child Attention-Deficit/Hyperactivity Disorder (ADHD) in the Context of Parental ADHD
Wang, C. H., Mazursky-Horowitz, H., & Chronis-Tuscano, A. (2014) · Current Psychiatry Reports · doi:10.1007/s11920-014-0474-8 · Cited by 39
Predictors of treatment outcome in adults with ADHD treated with OROS® methylphenidate
Buitelaar, J. K., Kooij, J. J. S., Ramos‐Quiroga, J. A., Dejonckheere, J., Casas, M., van Oene, J. C., Schäuble, B., & Trott, G.-E. (2010) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2010.12.016 · Cited by 39
“In brief, this was a 5-week, double-blind, randomized, placebo-controlled, parallelgroup, 4-arm, fixed-dose trial (Medori et al. 2008), followed by a 7week, open-label phase (Buitelaar et al.”
BackgroundMethodResultInfluentialSelf-citation
Criterion and concurrent validity of Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID) Spanish version
Ramos-Quiroga, J., Bosch, R., Richarte, V., Valero, S., Gómez-Barros, N., Nogueira, M., Palomar, G., Corrales, M., Sáez-Francàs, N., Corominas, M., et al. (2012) · Revista de Psiquiatría y Salud Mental (English Edition) · doi:10.1016/j.rpsmen.2012.05.002 · Cited by 17
Self-citation
OROS-methylphenidate efficacy on specific executive functioning deficits in adults with ADHD: A randomized, placebo-controlled cross-over study
Bron, T. I., Bijlenga, D., Boonstra, A. M., Breuk, M., Pardoen, W. F. H., Beekman, A. T. F., & Kooij, J. J. S. (2014) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2014.01.007 · Cited by 38
Self-citation
Toward Quality Care in ADHD: Defining the Goals of Treatment
Rostain, A., Jensen, P. S., Connor, D. F., Miesle, L. M., & Faraone, S. V. (2015) · Journal of Attention Disorders · doi:10.1177/1087054712473835 · Cited by 33
“Articles Containing Predefined Criteria for “Treatment Response” Abikoff et al., 2005; Adler, Goodman et al., 2008; Adler, Liebowitz et al., 2009; Ahmann et al., 2001; Armenteros, Lewis, & Davalos, 2007; Arnold et al., 2004; Bangs et al., 2007; Barkley, Guevremont, Anastopoulos, DuPaul, & Shelton, 1993; Biederman et a…”
Nonmedication treatments for adult ADHD: Evaluating impact on daily functioning and well-being.
Ramsay, J. R. (2010) · American Psychological Association eBooks · doi:10.1037/12056-000 · Cited by 33
Dose–Response Characteristics in Adolescents with Attention-Deficit/Hyperactivity Disorder Treated with OROS ® Methylphenidate in a 4-Week, Open-Label, Dose-Titration Study
Newcorn, J. H., Stein, M. A., & Cooper, K. (2010) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2009.0102 · Cited by 34
“However, ﬁndings from randomized ﬁxed dose trials with OROS (cid:1) (Medori et al. 2008), d -MPH extended release (Spencer et al. 2007), and mixed amphetamine salts extended release (Weisler et al. 2006) cast doubt on this conclusion because change in ADHD symptom scores was not appreciably…”
Influential
Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder
Mattingly, G. W., Weisler, R. H., Young, J. L., Adeyi, B. A., Dirks, B., Babcock, T., Lasser, R. A., Scheckner, B., & Goodman, D. W. (2013) · BMC Psychiatry · doi:10.1186/1471-244x-13-39 · Cited by 32
“In previous trials of adults with ADHD, clinical response has been defined either as at least a 30% decline from baseline in symptom scores on a validated rating scale of adult ADHD symptom severity [6,23,24] or as very much improved or much improved on ratings”
BackgroundMethod
Treatment discontinuation with methylphenidate in adults with attention deficit hyperactivity disorder: a meta-analysis of randomized clinical trials
Castells, X., Cunill, R., & Capellà, D. (2013) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-012-1390-7 · Cited by 41
Maintenance of response after open-label treatment with atomoxetine hydrochloride in international European and non-European adult outpatients with attention-deficit/hyperactivity disorder: a placebo-controlled, randomised withdrawal study
Upadhyaya, H., Ramos-Quiroga, J., Adler, L., Williams, D. R., Tanaka, Y., Lane, J. R., Escobar, R., Trzepacz, P., Camporeale, A., & Allen, A. (2013) · The European Journal of Psychiatry · doi:10.4321/s0213-61632013000300004 · Cited by 28
Self-citation
Assessment and Diagnosis of Adult ADHD: Clinical Challenges and Opportunities for Improving Patient Care
Weisler, R. H., & Goodman, D. W. (2008) · Primary psychiatry · Cited by 30
Further evidence of low adherence to stimulant treatment in adult ADHD: an electronic medical record study examining timely renewal of a stimulant prescription
Biederman, J., Fried, R. S., DiSalvo, M., Woodworth, K. Y., Biederman, I., Driscoll, H., Noyes, E. J., Faraone, S. V., & Perlis, R. H. (2020) · Psychopharmacology · doi:10.1007/s00213-020-05576-y · Cited by 36
“…due to the well-documented safety and efficacy of stimulants (Spencer et al. 2005; Spencer et al. 2007; Spencer et al. 2013; Biederman et al. 2006a; Medori et al. 2008; Faraone and Glatt 2009; Canadian ADHD Resource Alliance 2008; Kendall et al. 2008; Kooij et al. 2010; Faraone and Glatt 2010;…”
Background
A Novel Text Message Intervention to Improve Adherence to Stimulants in Adults With Attention Deficit/Hyperactivity Disorder
Biederman, J., Fried, R. S., DiSalvo, M., Woodworth, K. Y., Biederman, I., Noyes, E. J., Faraone, S. V., & Perlis, R. H. (2019) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000001055 · Cited by 30
Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: A 13-week, randomized, double-blind, placebo-controlled, fixed-dose study
Casas, M., Rösler, M., Sandra Kooij, J. J., Ginsberg, Y., Ramos-Quiroga, J. A., Heger, S., Berwaerts, J., Dejonckheere, J., van der Vorst, E., & Schäuble, B. (2013) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2011.600333 · Cited by 38
“Similarly, the percentage of responders ( 30% reduction in CAARS-O:SV at endpoint) in the placebo arm of the present study was 45.4 versus 27.4% in LAMDA-I (Medori et al. 2008).”
BackgroundMethodResultInfluentialSelf-citation
Correlation of symptomatic improvements with functional improvements and patient-reported outcomes in adults with attention-deficit/hyperactivity disorder treated with OROS methylphenidate
Rösler, M., Ginsberg, Y., Arngrim, T., Adamou, M., Niemelä, A., Dejonkheere, J., van Oene, J., & Schäuble, B. (2011) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2011.571283 · Cited by 28
“Baseline demographic and disease characteristics were similar in all four treatment arms and have been presented previously (Medori et al. 2008).”
BackgroundMethodResultInfluentialSelf-citation
Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate
Buitelaar, J. K., Casas, M., Philipsen, A., Kooij, J. J. S., Ramos‐Quiroga, J. A., Dejonckheere, J., van Oene, J. C., & Schäuble, B. (2011) · Psychological Medicine · doi:10.1017/s0033291711000845 · Cited by 30
“Stimulant medications such as methylphenidate (MPH) are highly effective for treatment of the core ADHD symptoms (Faraone et al. 2004 ; Medori et al. 2008 ; Peterson et al. 2008 ; Adler et al. 2009 ; Buitelaar et al. 2009a).”
BackgroundMethodInfluentialSelf-citation
Methylphenidate normalizes emotional processing in adult patients with attention-deficit/hyperactivity disorder: Preliminary findings
Conzelmann, A., Woidich, E., Mucha, R. F., Weyers, P., Jacob, C. P., Lesch, K.-P., & Pauli, P. (2011) · Brain Research · doi:10.1016/j.brainres.2010.12.085 · Cited by 27
Molecular imaging genetics of methylphenidate response in ADHD and substance use comorbidity
Szobot, C. M., Roman, T., Hutz, M. H., Genro, J. P., Shih, M. C., Hoexter, M. Q., Júnior, N., Pechansky, F., Bressan, R. A., & Rohde, L. A. (2010) · Synapse · doi:10.1002/syn.20829 · Cited by 27
“, 2006, 2007), on the contrary of pharmacological trials on ADHD without drug addicts (Adler et al., 2009; Medori et al., 2008).”
Background
A network meta-analysis of atomoxetine and osmotic release oral system methylphenidate in the treatment of attention-deficit/hyperactivity disorder in adult patients
Bushe, C., Day, K., Reed, V., Karlsdotter, K., Berggren, L., Pitcher, A., Televantou, F., & Haynes, V. (2016) · Journal of Psychopharmacology · doi:10.1177/0269881116636105 · Cited by 31
“Of the OROS methylphenidate studies included, one was a doseresponse study that assessed three different dose levels of OROS methylphenidate (Medori et al., 2008).”
Background
Open-Label Administration of Lisdexamfetamine Dimesylate Improves Executive Function Impairments and Symptoms of Attention-Deficit/Hyperactivity Disorder in Adults
Brown, T. E., Brams, M., Gao, J., Gasior, M., & Childress, A. (2010) · Postgraduate Medicine · doi:10.3810/pgm.2010.09.2196 · Cited by 29
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
Takahashi, N., Koh, T., Tominaga, Y., Saito, Y., Kashimoto, Y., & Matsumura, T. (2014) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2013.868925 · Cited by 25
“The calculation of sample size was based on results from a completed international Phase 3 study (Medori et al. 2008).”
BackgroundMethodResultInfluential
Adult Attention-Deficit/Hyperactivity Disorder Treatment and Cardiovascular Implications
Hammerness, P. G., Surman, C. B. H., & Chilton, A. (2011) · Current Psychiatry Reports · doi:10.1007/s11920-011-0213-3 · Cited by 24
An innovative SMS intervention to improve adherence to stimulants in children with ADHD: Preliminary findings
Fried, R. S., DiSalvo, M., Kelberman, C., Adler, A., McCafferty, D., Woodworth, K. Y., Green, A., Biederman, I., Faraone, S. V., & Biederman, J. (2020) · Journal of Psychopharmacology · doi:10.1177/0269881120908014 · Cited by 24
“…al., 2006a; Canadian ADHD Resource Alliance, 2008; Faraone and Buitelaar, 2010; Faraone and Glatt, 2010; Kendall et al., 2008; Kooij et al., 2010; Medori et al., 2008; Spencer et al., 2007, 2013) and help mitigate many of the complications (Barbaresi et al., 2007; Faraone et al., 2007),…”
Background
Baseline Severity of Parent-Perceived Inattentiveness Is Predictive of the Difference Between Subjective and Objective Methylphenidate Responses in Children with Attention-Deficit/Hyperactivity Disorder
Park, S., Kim, B.-N., Cho, S.-C., Kim, J.-W., Shin, M., Yoo, H., Han, D. H., & Cheong, J. H. (2013) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2013.0031 · Cited by 24
“…with treatment response (mostly measured by investigators) (Buitelaar et al. 1995; Spencer et al. 1995; Faraone et al. 2004; Biederman et al. 2006; Medori et al. 2008), we found younger ages and higher MPH doses in objective responders compared with objective nonresponders, but we did not ﬁnd…”
Does Pharmacological Treatment of ADHD in Adults Enhance Parenting Performance? Results of a Double-Blind Randomized Trial
Waxmonsky, J. G., Waschbusch, D. A., Babinski, D. E., Humphrey, H. H., Alfonso, A., Crum, K. I., Bernstein, M., Slavec, J., Augustus, J. N., & Pelham, W. E. (2014) · CNS Drugs · doi:10.1007/s40263-014-0165-3 · Cited by 26
“The dropout rate was elevated compared with shorter adult ADHD trials [23, 42] but comparable to those of an extended duration [24, 35, 43].”
Clinical utility of ADHD symptom thresholds to assess normalization of executive function with lisdexamfetamine dimesylate treatment in adults
Brown, T. E., Brams, M., Gasior, M., Adeyi, B., Babcock, T., Dirks, B., Scheckner, B., & Wigal, T. (2011) · Current Medical Research and Opinion · doi:10.1185/03007995.2011.605441 · Cited by 24
Safety and tolerability of flexible dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder
Challis (2009) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s6873 · Cited by 23
“We report the results of the seven-week open-label extension of the Medori and colleagues trial.(23) Patients who completed the double-blind phase or discontinued study medication due to poor tolerability received a flexible dose regimen of the medication (18–90 mg daily) so as to optimize efficacy and tolerability fo…”
Influential
Placebo Response and Its Predictors in Attention Deficit Hyperactivity Disorder: A Meta-Analysis and Comparison of Meta-Regression and MetaForest
Cervelló, X. C., Sáez, M., Barcheni, M., Cunill, R., Serrano, D., López, B., & Lissa, C. J. V. (2021) · The International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyab054 · Cited by 22
Effect of Methylphenidate on Height and Weight in Korean Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Retrospective Chart Review
Kim, H., Kim, S., Shon, S., Lee, J., Lee, H., & Choi, J. (2014) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2014.0025 · Cited by 23
“First, suppression of appetite is common among children taking MPH (Wilens et al. 2006; Medori et al. 2008; Newcorn et al. 2008), and reduced caloric intake can negatively affect potential growth in children.”
Criteria and Concurrent Validity of Adult ADHD Section of the Psychiatry Research Interview for Substance and Mental Disorders
Ramos‐Quiroga, J. A., Díaz-Digón, L., Comín, M., Bosch, R., Gloria Palomar, A., Chalita, J. P., Roncero, C., Nogueira, M., Torrens, M., & Casas, M. (2012) · Journal of Attention Disorders · doi:10.1177/1087054712454191 · Cited by 24
“…ADHD Diagnostic Interview for DSMIV-TR (CAADID) is one of the most frequently used semistructured diagnostic interviews for the assessment of adult ADHD (Arcos-Burgos et al., 2010; Daigre Blanco et al., 2009; Ramos-Quiroga, 2012; Epstein & Kollins, 2006; Medori et al., 2008; Ribasés et al., 2009).”
MethodSelf-citation
Critical analysis of the concept of adult attention-deficit hyperactivity disorder
Moncrieff, J., & Timimi, S. (2011) · The Psychiatrist · doi:10.1192/pb.bp.110.033423 · Cited by 18
Pharmacotherapy for Parents with Attention-Deficit Hyperactivity Disorder (ADHD)
Chronis-Tuscano, A. M., & Stein, M. A. (2012) · CNS Drugs · doi:10.2165/11633910-000000000-00000 · Cited by 24
Safety of stimulant treatment in attention deficit hyperactivity disorder: part II
Merkel, R. L. (2010) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2010.503238 · Cited by 21
Is Response to OROS‐Methylphenidate Treatment Moderated by Treatment with Antidepressants or Psychiatric Comorbidity? A Secondary Analysis from a Large Randomized Double Blind Study of Adults with ADHD
Biederman, J., Mick, E., Spencer, T., Surman, C., & Faraone, S. V. (2012) · CNS Neuroscience & Therapeutics · doi:10.1111/j.1755-5949.2010.00233.x · Cited by 20
“[14], for long-acting MPH delivered via an osmotic release oral system (OROS) [15,16], for IR dextroamphetamine, for dexmethylphenidate extended release [17], and for lisdexamfetamine dimesylate [18].”
Safety of stimulant treatment in attention deficit hyperactivity disorder: part I
Merkel, R. L., & Kuchibhatla, A. (2009) · Expert Opinion on Drug Safety · doi:10.1517/14740330903279956 · Cited by 20
Treatment Outcomes With Licensed and Unlicensed Stimulant Doses for Adults With Attention-Deficit/Hyperactivity Disorder
Farhat, L. C., Flores, J. M., Avila-Quintero, V. J., Polanczyk, G. V., Cipriani, A., Furukawa, T. A., Bloch, M. H., & Cortese, S. (2023) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2023.3985 · Cited by 20
Efficacy and Safety of PRC-063, Extended-Release Multilayer Methylphenidate in Adults with ADHD Including 6-Month Open-Label Extension
Weiss, M. D., Childress, A. C., & Donnelly, G. A. E. (2020) · Journal of Attention Disorders · doi:10.1177/1087054719896853 · Cited by 20
“…response rates of 17% to 40% have been previously observed in multisite clinical studies in adults with ADHD, depending on the definitions used (Medori et al., 2008; Waxmonsky et al., 2011), a review of 10 ADHD clinical development programs consisting of 17 clinical trials found increasing…”
Method
Management of attention-deficit hyperactivity disorder in adults: focus on methylphenidate hydrochloride
Moss, S. B. (2009) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s4101 · Cited by 19
“32,55,56 Patients appear to be fairly tolerant of side effects, one study showing only 4.3% of patients treated with OROS MPH discontinuing treatment due to an adverse event.”
Influential
Long-Term (1 Year) Safety and Efficacy of Methylphenidate Modified-Release Long-Acting Formulation (MPH-LA) in Adults with Attention-Deficit Hyperactivity Disorder: A 26-Week, Flexible-Dose, Open-Label Extension to a 40-Week, Double-Blind, Randomised, Placebo-Controlled Core Study
Ginsberg, Y., Arngrim, T., Philipsen, A., Gandhi, P., Chen, C.-W., Kumar, V., & Huss, M. (2014) · CNS Drugs · doi:10.1007/s40263-014-0180-4 · Cited by 20

Authors: Medori, R., Ramos-Quiroga, J. A., Casas, M., Kooij, J. J. S., Niemelä, A., Trott, G.-E., Lee, E., & Buitelaar, J. K.
Affiliations: Janssen (Germany) (DE)
Universitat Autònoma de Barcelona (ES)
Oulu University Hospital (FI)
Janssen (Belgium) (BE)
Radboud University Medical Center (NL)
Corresponding author: Medori, Rossella
ORCID: Casas, Miguel
Kooij, J.J.S.
Lee, Emma
Buitelaar, Jan K.
Venue: Biological Psychiatry
Publisher: Elsevier BV
Published: 2008-05
Volume: 63
Issue: 10
Pages: 981-989
ISSN: 0006-3223 (ISSN-L)
DOI: 10.1016/j.biopsych.2007.11.008
OpenAlex: W2167875798
Cited by: 186
References: 28
Citations by year: 2025: 3 · 2024: 5 · 2023: 6 · 2022: 9 · 2021: 3 · 2020: 6 · 2019: 6 · 2018: 4 · 2017: 7 · 2016: 6 · 2015: 4 · 2014: 17 · 2013: 13 · 2012: 19
FWCI: 18.15
Type: journal article
Language: en
Open access: green
hdl.handle.net
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Biological Psychiatry (publishedVersion)
PubMed (publishedVersion)
Radboud Repository (Radboud University) (submittedVersion)
Funders: Eli Lilly and Company
Cilag
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: adult ADHD, osmotic-release oral system, fixed-dose comparison, treatment efficacy, adverse events, appetite loss, blood pressure, Conners' Adult ADHD Rating Scale, dose-response relationship
MeSH terms: Administration, Oral, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Middle Aged, Psychiatric Status Rating Scales, Severity of Illness Index, Infusion Pumps, Implantable, Treatment Outcome

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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

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