Armodafinil as Adjunctive Therapy in Adults With Cognitive Deficits Associated With Schizophrenia: A 4-Week, Double-Blind, Placebo-Controlled Study
J Clin Psychiatry 2010;71(11):1475-1481
© Copyright 2014 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
Objective: To evaluate the efficacy and tolerability of armodafinil, the longer-lasting isomer of modafinil, as adjunctive therapy in patients with schizophrenia.
Method: This 4-week, randomized, double-blind, placebo-controlled, proof-of-concept study was conducted between July and December 2007. Patients had a history of stable schizophrenia (DSM-IV-TR criteria) for ≥ 8 weeks and were treated with oral risperidone, olanzapine, or paliperidone for ≥ 6 weeks at stable doses for ≥ 4 weeks. Patients were randomly assigned to once-daily placebo or armodafinil 50, 100, or 200 mg. The primary efficacy measure was the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery. Secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
Results: Sixty patients were randomly assigned (15 in each group). No apparent differences between groups in the MATRICS composite score were observed (mean ± SD change from baseline to final visit: armodafinil 50 mg, 1.9 ± 6.22; 100 mg, 2.8 ± 7.98; 200 mg, 2.9 ± 4.72; placebo, 2.2 ± 5.06). The mean ± SD changes in PANSS total scores were –6.3 ± 7.25 for armodafinil 200 mg and –1.7 ± 4.89 for placebo at final visit (effect size = 0.73; 95% CI, –0.08 to 1.54) and PANSS negative symptoms scores were –3.4 ± 2.07 and 0.1 ± 1.93 (effect size = 1.69; 95% CI, 0.78 to 2.60), respectively. Although reductions in SANS total score were observed with both armodafinil and placebo at final visit, no between-group difference was shown. Armodafinil was generally well tolerated, with diarrhea and headache the most commonly reported adverse events. There was no evidence of worsening of psychosis with adjunctive armodafinil.
Conclusions: In this 4-week study, adjunctive armodafinil was not associated with an improvement in cognitive measures, but armodafinil 200 mg/d appeared to mitigate the negative symptoms of schizophrenia. Treatment was generally well tolerated.
Trial Registration: clinicaltrials.gov Identifier: NCT00487942.
J Clin Psychiatry
Submitted: December 30, 2009; accepted May 20, 2010.
Online ahead of print: August 24, 2010 (doi:10.4088/JCP.09m05950gry).
Corresponding author: John M. Kane, MD, Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY 11004-1150 (email@example.com).