Elsevier

Biological Psychiatry

Volume 57, Issue 5, 1 March 2005, Pages 456-463
Biological Psychiatry

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

https://doi.org/10.1016/j.biopsych.2004.11.043Get rights and content

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.

Section snippets

Subjects

Subjects were 146 outpatient adults with ADHD aged between 19 and 60 years recruited from clinical referrals and advertisements in the local media. Subjects had to satisfy full diagnostic criteria for DSM-IV ADHD based on clinical assessment and confirmed by structured diagnostic interview (Biederman et al 1993). We excluded potential subjects if they had clinically significant chronic medical conditions; abnormal baseline laboratory values; IQ < 80; delirium, dementia, or amnestic disorders;

Results

There were 289 prospective participants who applied for entry into the study. Of these, 146 were enrolled. Of the 143 who were not enrolled, 42 did not complete the initial evaluation, 2 were excluded because of current substance or alcohol abuse, 19 did not meet full DSM-IV criteria for ADHD, 31 met entry criteria but were unable to commit to the demands of a controlled study, 9 were above the age limit, 8 were excluded for medical conditions or current use of concomitant medications (4 head

Discussion

In a large, double blind, placebo-controlled, parallel trial in adults with ADHD, treatment with MPH at an average oral daily dose of 1.1 mg/kg/day was consistently more effective than placebo. The overall response rate for ADHD symptoms was robust, clinically and statistically higher during MPH treatment than during placebo (76% vs. 19%; p < .0001). Treatment was safe and well tolerated. Improvement in ADHD symptoms was independent of gender, age, or lifetime history of psychiatric

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