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

NCT00546403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-02-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Modafinil

Adjunctive treatment with titrated dose of modafinil

DRUG

Placebo

Adjunctive treatment with placebo

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • Veterans Medical Research Foundation

    lead OTHER

Principal Investigators

  • James B Lohr, MD, PhD · Director, VA Center of Excellence for Stress and Mental Health (CESAMH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546403 on ClinicalTrials.gov