Viewing Study NCT00306475



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Last Modification Date: 2024-10-26 @ 9:23 AM
Study NCT ID: NCT00306475
Status: COMPLETED
Last Update Posted: 2010-01-07
First Post: 2006-03-22

Brief 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
Sponsor: Vanderbilt University
Organization: Vanderbilt University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2010-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None