NCT00546403

Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia

An Eight Week, Double-Blind, Placebo Controlled, Adjunctive Study of the Primary Effects of the Use of Flexible Doses of Modafinil 50mg to 200mg, on the Negative Symptoms, Cognition, and Excessive Daytime Sleepiness in Schizophrenic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. The beginning does will be 50mg for 2 weeks 2. The study medication will be increased to 100mg at the week 2 study visit 3. The study medication will be increased to 200mg at the week 4 study visit and will continue for the remaining 4 weeks of the study. If subjects are unable to tolerate dosage increases, the dose will be decreased to the previous level.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Modafinil	Adjunctive treatment with titrated dose of modafinil
DRUG	Placebo	Adjunctive treatment with placebo

Timeline

• Start date: 2003-02-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-10-19
• Last updated: 2009-02-24

Locations

1 site across 1 country: United States