Osmotic-Release Oral System Methylphenidate Augmentation of Antidepressant Monotherapy in Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Trial
J Clin Psychiatry 2008;69(1):87-94
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: To evaluate the efficacy, safety, and tolerability
of adjunctive osmotic-release oral system (OROS) methylphenidate in outpatients
with major depressive disorder (MDD) receiving a stable oral antidepressant
Method: This multicenter, double-blind, randomized,
placebo-controlled, parallel-group, 5-week trial enrolled 145 subjects who met
DSM-IV-TR criteria for MDD and who had failed 1 to 3 previous antidepressant
monotherapies (including current antidepressant) of adequate dose and duration.
Augmentation therapy was initiated with 18 mg of OROS methylphenidate and
increased to a maximum dose of 54 mg of OROS methylphenidate until an optimal
dose was achieved. Efficacy scales included the Montgomery-Asberg Depression
Rating Scale (MADRS), 7 atypical items from the 31-item Hamilton Rating Scale
for Depression, the Clinical Global Impressions-Severity of Illness (CGI-S)
scale, the CGI-Improvement scale (CGI-I), the Sex Effects scale, the
Multidimensional Assessment of Fatigue (MAF) scale, and the Apathy Evaluation
Scale (AES). Subjects were recruited at 17 community and academic centers
across Canada. The study was conducted from June 8, 2005, to April 18, 2006.
Results: There was no statistically significant difference
between the groups at endpoint on the MADRS. OROS methylphenidate was superior
to placebo in improving apathy and fatigue as measured by the AES and the MAF.
Statistically significant differences using mixed-model analysis were observed
on the AES at all visits and at endpoint (p = .01) and on the MAF (p < .01). No
differences were observed on other secondary measures, including the CGI-I and
CGI-S. There were no clinically significant findings on electrocardiogram.
Conclusions: OROS methylphenidate did not demonstrate
statistical significance on the MADRS at endpoint. Apathy and fatigue were
significantly improved with OROS methylphenidate treatment, which was well
tolerated with minimal side effects.