Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
- Registration Number
- NCT00838227
- Lead Sponsor
- Manhattan Psychiatric Center
- 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
- Detailed Description
This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description One arm modafinil Study withdrawn due to lack of funds.
- Primary Outcome Measures
Name Time Method Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB) 8 weeks Study withdrawn due to lack of funds.
- Secondary Outcome Measures
Name Time Method Sedation and weight changes 8 weeks Study withdrawn due to lack of funds.