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)?

Phase 4

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: divalproex sodium ER; Drug: placebo

• Registration Number: NCT00306475
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-23
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	divalproex sodium ER	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Improvements in cognition and psychopathology	six weeks

Trial Locations

Locations (1)

Psychiatric Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States