Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: One arm Study withdrawn due to lack of funds. |
Drug: modafinil
Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen
Other Names:
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Outcome Measures
Primary Outcome Measures
- Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) [8 weeks]
Study withdrawn due to lack of funds.
Secondary Outcome Measures
- Sedation and weight changes [8 weeks]
Study withdrawn due to lack of funds.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years
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Auditory and visual acuity adequate to complete cognitive tests
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Stable dose of antipsychotics for at least 2 weeks prior to entry
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Good physical health determined by complete physical examination, laboratory tests, and EKG
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Capacity and willingness to give written informed consent.
Exclusion Criteria:
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Inability to read or speak English
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Documented disease of the central nervous system
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History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
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Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;
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HIV positive
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Patients on antidepressants, including monoamine oxidase inhibitors
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Uncontrolled hypertension
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Pregnancy
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Patients with a current diagnosis of substance dependence
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Significant history of violence
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History of an eating disorder
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Ready for discharge within the following 8 weeks.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Manhattan Psychiatric Center
Investigators
- Principal Investigator: Jean-Pierre Lindenmayer, MD, Manhattan Psychiatric Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 07I/C41-00