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Sponsors and Collaborators: |
Veterans Medical Research Foundation Cephalon |
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Information provided by: | Veterans Medical Research Foundation |
ClinicalTrials.gov Identifier: | NCT00546403 |
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.
Condition | Intervention |
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Schizophrenia |
Drug: Modafinil Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | 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 |
Enrollment: | 26 |
Study Start Date: | February 2003 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Adjunctive treatment with placebo
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Drug: Placebo
Adjunctive treatment with placebo
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Modafinil: Experimental
Treatment with titrated dose of study drug, modafinil.
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Drug: Modafinil
Adjunctive treatment with titrated dose of modafinil
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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:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No uncontrolled hypertension, as defined below (subjects cannot have any of the following):
Exclusion Criteria:
United States, California | |
VA Healthcare System, Department of Psychiatry | |
San Diego, California, United States, 92161 |
Principal Investigator: | James B Lohr, MD, PhD | Director, VA Center of Excellence for Stress and Mental Health (CESAMH) |
Responsible Party: | Veterans Medical Research Foundation ( James Lohr, MD ) |
Study ID Numbers: | C1538a-633 |
Study First Received: | October 17, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00546403 History of Changes |
Health Authority: | United States: Institutional Review Board |
Excessive Daytime Sleepiness |
Schizophrenia Mental Disorders Central Nervous System Stimulants Psychotic Disorders |
Neuroprotective Agents Modafinil Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Modafinil Schizophrenia and Disorders with Psychotic Features |