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

Study Overview
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Brief Summary
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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
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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: The beginning does will be 50mg for 2 weeks The study medication will be increased to 100mg at the week 2 study visit 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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Modafinil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be able to communicate and give voluntary informed consent Subjects must be of the male gender Between the ages of 18 to 65 years. A diagnosis of Schizophrenia or Schizoaffective disorder as determined by DSM-IV criteria. Not conservatorized A negative symptom score on the PANSS of >= 20 and an MMSE score of >24 No clinical evidence of a current unstable medical illness No current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness) No history of drug or alcohol dependence in the past 2 years No evidence of drug or alcohol abuse in the past year, as determined by the DSM-IV criteria. No diagnosis of Narcolepsy as determined by DSM-IV criteria Must have an approved contact person for the duration of the study May be on a stable dose of SSRI for depressive symptoms No history of aggression No uncontrolled hypertension, as defined below (subjects cannot have any of the following): a new diagnosis of hypertension, or a change in antihypertensive medications in the past 30 days, or acute hypertension (systolic>160mmHg, diastolic>100mmHg) Maybe on a stable dose of a benzodiazepine The following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, MAO inhibitors, anticoagulant, TCA's, or barbiturates. Be on a stable does of an atypical neuroleptic May be on a stable does of an anticonvulsant for mood stabilization Exclusion Criteria: Subjects cannot be female.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Adjunctive treatment with placebo | Drug: Placebo<br>* Adjunctive treatment with placebo<br>|
| Experimental: Modafinil<br>Treatment with titrated dose of study drug, modafinil. | Drug: Modafinil<br>* Adjunctive treatment with titrated dose of modafinil<br>* Other names: Provigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS, and Sleep/wake activity measured using the Actillume (Ambulatory Monitoring, Inc.) |  | baseline, one month, two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Assessments that target cognitive abilities. |  | baseline, one month, two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive Daytime Sleepiness