An interventional study of Modafinil and Placebo in Schizophrenia, sponsored by Veterans Medical Research Foundation. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-02-24.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment
The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to examine the effect of modafinil on cognitive functioning of schizophrenic patients.
Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil has been shown to increase alertness in individuals who are pathologically sleepy (Study C1538a/301/NAIUS).
Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value of >=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo, supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The titration schedule will be as follows:
173 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
This study's enrollment of 26 is below the median of 90 across 133 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
No uncontrolled hypertension, as defined below (subjects cannot have any of the following):
Exclusion Criteria:
Adjunctive treatment with placebo
Drug: Placebo
Treatment with titrated dose of study drug, modafinil.
Drug: Modafinil
Adjunctive treatment with titrated dose of modafinil
Also known as: Provigil
Adjunctive treatment with placebo
PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.)
Time frame: baseline, one month, two months
Neuropsychological Assessments that target cognitive abilities.
Time frame: baseline, one month, two months
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Disorders of Excessive Somnolence→
Veterans Medical Research Foundation