Schizophrenia Clinical Trial
Official title:
Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?
The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.
Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective
disorder. It has been found that cognitive dysfunction may be even more important than
positive or negative symptoms in predicting functional outcomes such as community
adjustment, ability to work, social interactions, and caretaker burden. Preclinical data
from our laboratory provided the rationale for a clinical trial to test whether divalproex
sodium ER can improve cognitive impairment in patients.
The major objective of this proposal is to test the hypothesis that the addition of
divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly
improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a
double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or
schizoaffective disorder.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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