Status:
WITHDRAWN
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder
Lead Sponsor:
Manhattan Psychiatric Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 ...
Detailed Description
This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00838227
Start Date
February 1 2008
End Date
June 1 2012
Last Update
October 14 2020
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