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J Clin Psychiatry. 2009 Dec;70(12):1674-80. doi: 10.4088/JCP.08m04683. Epub 2009 Aug 11.

Modafinil for clozapine-treated schizophrenia patients: a double-blind, placebo-controlled pilot trial.

Author information

1
Massachusetts General Hospital Schizophrenia Program, Freedom Trail Clinic, Boston, MA 02114, USA. ofreudenreich@partners.org

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.

PMID:
19689921
PMCID:
PMC5038350
DOI:
10.4088/JCP.08m04683
[Indexed for MEDLINE]
Free PMC Article

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