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A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder
Abstract
Background The few controlled studies of methylphenidate (MPH) in adults with attention deficit/hyperactivity disorder (ADHD) have reported equivocal results. A previous, pilot study by our group suggested that these results were due to inadequate dosing. Method We conducted a randomized, 6-week, placebo-controlled, parallel study of MPH in 146 adult patients with DSM-IV ADHD using standardized instruments for diagnosis, separate assessments of ADHD, depressive and anxiety symptoms, and a robust average oral daily dose of 1.1 mg/kg/day. Results We found a marked therapeutic response for the MPH treatment of ADHD symptoms that exceeded the placebo response (76% vs. 19%). Treatment was safe and well tolerated. Response to MPH was independent of socioeconomic status, gender, and lifetime history of psychiatric comorbidity. Conclusions These results confirm that robust doses of MPH are effective in the treatment of adult ADHD.
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“Stimulants are effective in about 70% of patients with ADHD in controlled studies [265-267] depending on the study design and maximum drug dosage.”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [267]
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“…response rates ranging from 25% to 78% for methylphenidate (Biederman et al., 2006; Mattes, Boswell, & Oliver, 1984; Spencer et al., 1995; Spencer et al., 2005) and response rates ranging from 54% to 70% for amphetamine (Horrigan & Barnhill, 2000; Paterson, Douglas, Hallmayer, Hagan, &…”
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Self-citationInattention, but not OCD, predicts the core features of Hoarding Disorder
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“Stimulants such as methylphenidate have been shown to improve attention and related cognitive functions in placebo-controlled randomized controlled trials in children and adults with ADHD (Medori et al., 2008; Pliszka, 2007; Pliszka et al., 2006; Scheffler et al., 2009; Spencer et al., 2005).”
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Self-citationSobanski, E., Brüggemann, D., Alm, B., Kern, S., Philipsen, A., Schmalzried, H., Heßlinger, B., Waschkowski, H., & Rietschel, M. (2007) · European Psychiatry · doi:10.1016/j.eurpsy.2007.09.007 · Cited by 157
“These results are in accordance with the results of prior studies obtained in clinically and population-based samples of adults with ADHD, which report high lifetime rates of comorbid psychiatric disorders in up to 89% of the subjects with elevated rates of depressive syndromes and substance use disorders [7,14,21,22,…”
ResultSpencer, T. J., Biederman, J., Madras, B. K., Dougherty, D. D., Bonab, A. A., Livni, E., Meltzer, P. C., Martin, J., Rauch, S., & Fischman, A. J. (2007) · Biological Psychiatry · doi:10.1016/j.biopsych.2006.12.008 · Cited by 150
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Attention deficit hyperactivity disorder in adults
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“…improved ” or “ very much improved ” (score of 2) on Clinical Global Impression – Improvement (CGI-I) plus 30% reduction in ADHD Investigator System Report Scale (AISRS) score from baseline was achieved by signifi cantly more patients receiving MPH-IR, compared with placebo (Spencer et al. 2005).”
Young, Z., Moghaddam, N., & Tickle, A. (2020) · Journal of Attention Disorders · doi:10.1177/1087054716664413 · Cited by 138
“The first-line treatment for ADHD is pharmacotherapy (National Institute for Health and Care Excellence [NICE], 2016), with most research on adults focusing on medication efficacy (Faraone & Glatt, 2010; Spencer et al., 2005; Wilens et al., 2001), The effectiveness of pharmacotherapy in adult ADHD is variable; however…”
BackgroundGender differences in ADHD: implications for psychosocial treatments
Rucklidge, J. J. (2008) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.8.4.643 · Cited by 142
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“Finally, the mean dose of methylphenidate was less than that reported in ADHD studies.(12) In conclusion, the study failed to show a statistically significant benefit for augmentation with extended-release methylphenidate in patients with MDD without psychotic features who are not responsive to antidepressant therapy.”
ResultPharmacotherapy of adult attention deficit hyperactivity disorder (ADHD): a meta-analysis
Mészáros, Á., Czobor, P., Bálint, S., Komlósi, S., Simon, V., & Bitter, I. (2009) · The International Journal of Neuropsychopharmacology · doi:10.1017/s1461145709990198 · Cited by 138
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The use of methylphenidate among students: the future of enhancement?
Outram, S. M. (2010) · Journal of Medical Ethics · doi:10.1136/jme.2009.034421 · Cited by 132
“Similarly, Spencer et al have recorded that “of individual side effects reported, only MPH-associated [methylphenidate-associated] appetite suppression, dry mouth, and mild moodiness reached our threshold for statistical significance”.(25) However, in a recent systematic review of the use of methylphenidate in adults,…”
ResultMick, E. O., McManus, D. D., & Goldberg, R. J. (2012) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2012.06.011 · Cited by 136
“Two study samples contributed to multiple publications (Spencer et al., 2005, Biederman et al., 2006, Biederman et al., 2010) but in only a direct comparison of the active treatments (OROS-MPH and MPH-tid) (Biederman et al., 2007) against a pooled placebo group was the data presented with enough…”
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“Our fi ndings are in line with earlier research demonstrating no specifi c treatment effects on depression and anxiety by MPH (Spencer et al. 2005; Biederman et al. 2006; Jain et al. 2007).”
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“However, in humans, the improvement of impulse control by stimulants seems not restricted to children, as it has been also observed in normal and ADHD adults (de Wit et al. 2002; Spencer et al. 2005).”
BackgroundAn update on the pharmacotherapy of attention-deficit/hyperactivity disorder in adults
Wilens, T. E., Morrison, N. R., & Prince, J. B. (2011) · Expert Review of Neurotherapeutics · doi:10.1586/ern.11.137 · Cited by 117
Self-citationLong-term efficacy and safety outcomes with OROS-MPH in adults with ADHD
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“Furthermore, OROS-MPH was well tolerated during the long-term open-label phase, with an adverseevent profile similar to other studies of MPH in adults with ADHD (Adler et al. 2011; Bouffard et al. 2003; Kooij et al. 2004; Medori et al. 2008; Spencer et al. 2005) and no new or unexpected adverse events were reported wi…”
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“…(Reimherr et al. 2005; Wilens et al. 2005, 2001), shorter-acting stimulants (Carpentier et al. 2005; Kooij et al. 2004; Schubiner et al. 2002; Spencer et al. 2005, 2001, 1995; Weiss et al. 2006; Wender et al. 1985), and longer-acting stimulants (Biederman et al. 2006; Levin et al. 2006,…”
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“Based on preliminary findings and previous studies, 14,25,26 the aim was to detect a mean difference of 9 units in the CAARS-O:SV (range 0–54) between groups from baseline until the end-point at week 5.”
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“The objective of the study was to evaluate the efficacy and safety of OROS methylphenidate compared with placebo in adults with ADHD.”
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“, 2004; McGough & Barkley, 2004) as observed in children with the disorder and a similar response to treatment with methylphenidate when equipotent doses are used (i.e., 1.0 mg/kg; Biederman, Mick, et al., 2006; Spencer et al., 2005).”
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“some studies showing high efficacy (Spencer et al. 2005) while others found no difference from placebo (Levin et al.”
ResultStimulants and Sudden Death: What Is a Physician to Do?
Wilens, T. E., Prince, J. B., Spencer, T. J., & Biederman, J. (2006) · PEDIATRICS · doi:10.1542/peds.2006-0942 · Cited by 86
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“In the last years, growing evidence showed that in many patients the disorder persists into adulthood; meanwhile, adult ADHD has been recognized in the literature as a valid clinical entity, affecting as many as 2–4 % of adults [ 18 ].”
BackgroundAttenuated Tonic and Enhanced Phasic Release of Dopamine in Attention Deficit Hyperactivity Disorder
Badgaiyan, R. D., Sinha, S., Sajjad, M., & Wack, D. S. (2015) · PLOS ONE · doi:10.1371/journal.pone.0137326 · Cited by 84
Bupropion for attention deficit hyperactivity disorder (ADHD) in adults.
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A One Year Trial of Methylphenidate in the Treatment of ADHD
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“…the findings in the short-term trial support the conclusions of the robustness of the effects of methylphenidate found in seven previous studies of methylphenidate (Guilatieri et al., 1985; Kooji et al., 2004; Mattes et al., 1984; Spencer et al., 1995, 2005; Wender et al., 1985; Wood et al., 1976).”
ResultHall, C. L., Newell, K. A., Taylor, J. L., Sayal, K. S., Swift, K. D., & Hollis, C. P. (2013) · BMC Psychiatry · doi:10.1186/1471-244x-13-186 · Cited by 77
Safety of therapeutic methylphenidate in adults: a systematic review of the evidence
Godfrey, J. (2008) · Journal of Psychopharmacology · doi:10.1177/0269881108089809 · Cited by 77
“Stein (2003) reported a 9-month non-blind, non-randomised trial of OROS methylphenidate for patients with ADHD, including both adolescents and adults.”
BackgroundSchatz, N. K., Fabiano, G. A., Cunningham, C. E., dosReis, S., Waschbusch, D. A., Jerome, S., Lupas, K., & Morris, K. L. (2015) · The Patient - Patient-Centered Outcomes Research · doi:10.1007/s40271-015-0112-5 · Cited by 74
“Stimulant medication and behavioral interventions are evidence-based interventions for youth with ADHD [4–7], and there is evidence for the efficacy of stimulant medication for adults with ADHD [8].”
BackgroundWeiss, M. D., Gibbins, C., Goodman, D. W., Hodgkins, P., Landgraf, J. M., & Faraone, S. V. (2010) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.08m04709pur · Cited by 74
Self-citationNonmedical Use and Diversion of ADHD Stimulants Among U.S. Adults Ages 18-49
Cassidy, T. A., Varughese, S., Russo, L., Budman, S. H., Eaton, T. A., & Butler, S. F. (2012) · Journal of Attention Disorders · doi:10.1177/1087054712468486 · Cited by 71
“Prescription stimulants have potential for abuse liability (Kollins et al., 2001; Spencer et al., 2005) and can pose health risks when used inappropriately by patients and others for whom the medication was not intended (McCabe, 2006).”
BackgroundThe Complexity of ADHD: Diagnosis and Treatment of the Adult Patient With Comorbidities
Newcorn, J. H., Weiss, M., & Stein, M. A. (2007) · CNS Spectrums · doi:10.1017/s1092852900026158 · Cited by 66
Biederman, J., Mick, E., Fried, R., Wilner, N., Spencer, T. J., & Faraone, S. V. (2011) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2010.11.005 · Cited by 67
“Acute efficacy, tolerability and safety have been demonstrated for immediate release (IR) methylphenidate (MPH) administered t.i.d. (Spencer et al., 2005), for long-acting MPH delivered via an osmotic release oral system (OROS) (Biederman et al., 2006b; Medori et al., 2008), and for…”
BackgroundSelf-citationPerspectives on the assessment and treatment of adult ADHD in hypersexual men
Reid, R. C., Davtian, M., Lenartowicz, A., Torrevillas, R. M., & FONG, T. W. (2013) · Neuropsychiatry · doi:10.2217/npy.13.31 · Cited by 67
Potter, A. S., Schaubhut, G., & Shipman, M. (2014) · CNS Drugs · doi:10.1007/s40263-014-0208-9 · Cited by 64
“However, approximately 25–30 % of adults with ADHD do not have an adequate response to current approved treatments [35].”
BackgroundConklin, H. M., Helton, S., Ashford, J. M., Mulhern, R. K., Reddick, W. E., Brown, R. T., Bonner, M. J., Jasper, B. W., Wu, S., Xiong, X., et al. (2009) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsp044 · Cited by 66
“Demographic factors including gender, years of education, and socioeconomic status have generally not been predictive of medication response (Hermens et al., 2005; Spencer et al., 2005).”
BackgroundADHD in old age: a review of the literature and proposal for assessment and treatment
Kooij, J. J. S., Michielsen, M., Kruithof, H. C., & Bijlenga, D. (2016) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2016.1204914 · Cited by 69
Bymaster, F. P., Gołembiowska, K., Kowalska, M., Choi, Y. K., & Tarazi, F. I. (2012) · Synapse · doi:10.1002/syn.21538 · Cited by 65
“The stimulants have an immediate onset of action in ADHD, are effective against all three core deficits of the disorder, and have a response rate of about 70% (Spencer et al., 2005).”
BackgroundBiederman, J., Fried, R. S., DiSalvo, M., Storch, B., Pulli, A., Woodworth, K. Y., Biederman, I., Faraone, S. V., & Perlis, R. H. (2019) · Psychiatric Services · doi:10.1176/appi.ps.201800515 · Cited by 69
Self-citationSantosh, P. J., Sattar, S., & Canagaratnam, M. (2011) · CNS Drugs · doi:10.2165/11593070-000000000-00000 · Cited by 62
“Spencer et al.([29]) conducted a large, 6-week, double-blind study in 146 adults with ADHD, which supported the greater efficacy of higher doses ofmethylphenidate IR.”
BackgroundInfluentialImmediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Epstein, T., Patsopoulos, N. A., & Weiser, M. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005041.pub3 · Cited by 62
RetractedADHD in Children, Adolescents, and Adults
Katragadda, S., & Schubiner, H. (2007) · Primary Care: Clinics in Office Practice · doi:10.1016/j.pop.2007.04.012 · Cited by 61
Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Epstein, T., Patsopoulos, N. A., & Weiser, M. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005041.pub2 · Cited by 65
RetractedWang, P., Zhang, X., Fu, T., Li, S., Li, B., Xue, W., Yao, X., Chen, Y., & Zhu, F. (2017) · ACS Chemical Neuroscience · doi:10.1021/acschemneuro.7b00173 · Cited by 60
Biederman, J., Mick, E., Surman, C., Doyle, R., Hammerness, P., Kotarski, M., & Spencer, T. (2010) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e3181ee84a7 · Cited by 76
“Tense/jittery 20 (18) 3 (3) 15 (24) 4 (12) 3 (25) 1 (9)”
InfluentialSelf-citationWang, P., Fu, T., Zhang, X., Yang, F., Zheng, G., Xue, W., Chen, Y., Yao, X., & Zhu, F. (2017) · Biochimica et Biophysica Acta (BBA) - General Subjects · doi:10.1016/j.bbagen.2017.07.022 · Cited by 56
Gan, J., Galer, P. D., Ma, D., Chen, C., & Xiong, T. (2019) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2019.0059 · Cited by 59
“Unfortunately, despite treatment advancements only 30%–70% of patients respond to currently available ADHD therapies (Spencer et al. 2005; Chan et al. 2016).”
Surman, C. B. H., Monuteaux, M. C., Petty, C. R., Faraone, S. V., Spencer, T. J., Chu, N. F., & Biederman, J. (2010) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.09m05344pur · Cited by 54
Self-citationvan Andel, E., Bijlenga, D., Vogel, S. W. N., Beekman, A. T. F., & Kooij, J. J. S. (2020) · Chronobiology International · doi:10.1080/07420528.2020.1835943 · Cited by 61
“In clinical practice, a reduction of at least 30% of the total score indicates clinically relevant treatment effects (Kooij et al. 2004; Spencer et al. 2005).”
BackgroundMethylphenidate use in pregnancy and lactation: a systematic review of evidence
Bolea-Alamanac, B. M., Green, A. C., Verma, G., Maxwell, P., & Davies, S. (2013) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12138 · Cited by 54
Ramos-Quiroga, J. A., Bosch, R., Castells, X., Valero, S., Nogueira, M., Gómez, N., Yelmo, S., Ferrer, M., Martínez, Y., & Casas, M. (2008) · CNS Drugs · doi:10.2165/00023210-200822070-00005 · Cited by 54
Rucklidge, J. J., Taylor, M. R., & Whitehead, K. (2010) · Journal of Attention Disorders · doi:10.1177/1087054709356173 · Cited by 62
Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD
Adler, L. A., Spencer, T., McGough, J. J., Jiang, H., & Muniz, R. (2009) · Journal of Attention Disorders · doi:10.1177/1087054708320397 · Cited by 53
“In other short-term studies, a mean loss of 2.4 kg was reported after 6 weeks of treatment with mean MPH doses of 1.1 mg/kg/d (Spencer et al., 2005), and a mean loss of 1.8 kg was reported after 3 weeks of treatment with mixed amphetamine salts 54 mg/d and 4 weeks of placebo (Spencer et al., 2001).”
BackgroundMethodResultInfluentialSelf-citationMick, E. O., Biederman, J., Spencer, T. J., Faraone, S. V., & Sklar, P. B. (2006) · American Journal of Medical Genetics Part B Neuropsychiatric Genetics · doi:10.1002/ajmg.b.30376 · Cited by 51
“Our studies were designed to determine optimal dose after either a 3-week forced titration [Spencer et al., 2005] or aflexible dosing protocol [Biedermanet al.”
BackgroundMethodResultInfluentialSelf-citation
Metadata
- Authors
- Spencer, T., Biederman, J., Wilens, T., Doyle, R., Surman, C., Prince, J., Mick, E., Aleardi, M., Herzig, K., & Faraone, S.
- Affiliations
- Harvard University (US)
- Corresponding author
- Spencer, Thomas
- Venue
- Biological Psychiatry
- Publisher
- Elsevier BV
- Published
- 2005-03
- Volume
- 57
- Issue
- 5
- Pages
- 456-463
- ISSN
- 0006-3223 (ISSN-L)
- OpenAlex
- W2053924394
- Cited by
- 385
- References
- 60
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 8 · 2023: 16 · 2022: 8 · 2021: 10 · 2020: 9 · 2019: 12 · 2018: 7 · 2017: 15 · 2016: 12 · 2015: 15 · 2014: 16 · 2013: 19 · 2012: 25
- FWCI
- 21.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (R29MH57511, R29MH057511)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- methylphenidate, adult ADHD, ADHD medication, placebo response, dose-response relationship, depressive symptoms, anxiety symptoms, psychiatric comorbidity, treatment safety
- MeSH terms
- Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Demography, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Methylphenidate, Middle Aged, Neuropsychological Tests, Placebos, Psychiatric Status Rating Scales, Treatment Outcome
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