Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

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

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

This study was withdrawn due to no source of funding to implement the study.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

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.