A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating
dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of
clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be
initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4
weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based
upon persistence of sedation versus emergence of side effects.