Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Study Overview
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Brief Summary
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This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens

Detailed Description
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This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.

Official Title
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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: modafinil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years Auditory and visual acuity adequate to complete cognitive tests Stable dose of antipsychotics for at least 2 weeks prior to entry Good physical health determined by complete physical examination, laboratory tests, and EKG Capacity and willingness to give written informed consent. Exclusion Criteria: Inability to read or speak English Documented disease of the central nervous system History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation) Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions; HIV positive Patients on antidepressants, including monoamine oxidase inhibitors Uncontrolled hypertension Pregnancy Patients with a current diagnosis of substance dependence Significant history of violence History of an eating disorder Ready for discharge within the following 8 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One arm<br>Study withdrawn due to lack of funds. | Drug: modafinil<br>* Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen<br>* Other names: Provigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) | Study withdrawn due to lack of funds. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation and weight changes | Study withdrawn due to lack of funds. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cognition, Obesity, Sedation