A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder

Thomas Spencer; Joseph Biederman; Timothy Wilens; Robert Doyle; Craig Surman; Jefferson Prince; Eric Mick; Megan Aleardi; Kathleen Herzig; Stephen Faraone

doi:10.1016/j.biopsych.2004.11.043

A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder

Thomas Spencer, Joseph Biederman, Timothy Wilens, Robert Doyle, Craig Surman, Jefferson Prince, Eric Mick, Megan Aleardi, Kathleen Herzig, Stephen Faraone

Research output: Contribution to journal › Article › peer-review

309 Scopus citations

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.

Original language	English
Pages (from-to)	456-463
Number of pages	8
Journal	Biological Psychiatry
Volume	57
Issue number	5
DOIs	https://doi.org/10.1016/j.biopsych.2004.11.043
State	Published - 1 Mar 2005
Externally published	Yes

Keywords

ADHD
Adult
Methylphenidate
Psychopharmacology
Randomized trial
Stimulant

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10.1016/j.biopsych.2004.11.043

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title = "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.",

keywords = "ADHD, Adult, Methylphenidate, Psychopharmacology, Randomized trial, Stimulant",

author = "Thomas Spencer and Joseph Biederman and Timothy Wilens and Robert Doyle and Craig Surman and Jefferson Prince and Eric Mick and Megan Aleardi and Kathleen Herzig and Stephen Faraone",

note = "Funding Information: This study was supported by funding from National Institute of Mental Health (NIMH) Grant No. R29MH57511 (TS). Novartis Pharmaceuticals Corporation supported a portion of the cost of active medication. Funding Information: We thank John Vetrano, Harold Demonaco, and the Pharmacy staff at Massachusetts General Hospital. TS, JB, and TW are on the Speakers{\textquoteright} Bureau and Advisory Board of Novartis Pharmaceuticals. They also receive grant support from NIMH and NIDA.",

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doi = "10.1016/j.biopsych.2004.11.043",

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AU - Spencer, Thomas

AU - Biederman, Joseph

AU - Wilens, Timothy

AU - Doyle, Robert

AU - Surman, Craig

AU - Prince, Jefferson

AU - Mick, Eric

AU - Aleardi, Megan

AU - Herzig, Kathleen

AU - Faraone, Stephen

N1 - Funding Information: This study was supported by funding from National Institute of Mental Health (NIMH) Grant No. R29MH57511 (TS). Novartis Pharmaceuticals Corporation supported a portion of the cost of active medication. Funding Information: We thank John Vetrano, Harold Demonaco, and the Pharmacy staff at Massachusetts General Hospital. TS, JB, and TW are on the Speakers’ Bureau and Advisory Board of Novartis Pharmaceuticals. They also receive grant support from NIMH and NIDA.

PY - 2005/3/1

Y1 - 2005/3/1

N2 - 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.

AB - 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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KW - Randomized trial

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A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder

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Keywords

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