Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

• Status: Withdrawn
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Psychiatric Center
• Treatments: Armodafinil; Modafinil

Criteria

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.