This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Articles

Modafinil for Clozapine-Treated Schizophrenia Patients: A Double-Blind, Placebo-Controlled Pilot Trial

Oliver Freudenreich, MD; David C. Henderson, MD; Eric A. Macklin, PhD; A. Eden Evins, MD, MPH; Xiaoduo Fan, MD; Cori Cather, PhD; Jared P. Walsh, BA; and Donald C. Goff, MD

Published: August 11, 2009

Article Abstract

Background: Patients with schizophrenia often suffer from cognitive deficits and negative symptoms that are poorly responsive to antipsychotics including clozapine. Clozapine-induced sedation can worsen cognition and impair social and occupational functioning.

Objectives: To evaluate the efficacy, tolerability, and safety of modafinil for negative symptoms, cognition, and wakefulness/fatigue in DSM-IV-diagnosed schizophrenia patients treated with clozapine.

Method: A double-blind, placebo-controlled, flexible-dosed 8-week pilot trial was conducted between September 2003 and September 2007, adding modafinil up to 300 mg/d to stabilized schizophrenia outpatients receiving clozapine.
Psychopathology, cognition, and wakefulness/fatigue were assessed with standard rating scales.

Results: Thirty-five patients were randomly assigned to treatment with study drug and included in the analysis. Modafinil did not reduce negative symptoms or wakefulness/fatigue or improve cognition compared to placebo. Modafinil was
well tolerated and did not worsen psychosis.

Conclusions: Results of this pilot trial do not support routine use of modafinil to treat negative symptoms, cognitive deficits, or wakefulness/fatigue in patients on clozapine. However, given our limited power to detect a treatment effect and the clear possibility of a type II error, larger trials are needed to resolve or refute a potential therapeutic effect of uncertain magnitude.

Trial Registration: clinicaltrials.gov Identifier: NCT00573417

Submitted: September 6, 2008; accepted November 11, 2008.

Online ahead of print: August 11, 2009.

Corresponding author: Oliver Freudenreich, MD, MGH Schizophrenia Program, Freedom Trail Clinic, 25 Staniford St, 2nd Floor, Boston, MA 02114 (ofreudenreich@partners.org).

Volume: 70

Quick Links: Schizophrenia and Schizoaffective Disorders

Continue Reading…

Subscribe to read the entire article

$40.00

Buy this Article as a PDF

References

Sign-up to stay
up-to-date today!

SUBSCRIBE

Already registered? Sign In

Case Report

Safety and Tolerability of Concomitant Intranasal Esketamine Treatment With Irreversible, Nonselective MAOIs: A Case Series

Three cases suggest that concomitant use of intranasal esketamine with an irreversible, nonselective MAOI is safe in...

Read More...