At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 60 enrolled

Drug / intervention

Divalproex Sodium Extended-Release Tablets +1 moredrug

Likely dose

Divalproex Sodium Extended-Release Tablets 1000 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00306475

NCT00306475Phase 4Completed

Compare CT.gov

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)?

Northwestern University·interventional·Posted Mar 23, 2006·Updated Jun 27, 2025

In Brief

A Phase 4 clinical trial evaluating Divalproex Sodium Extended-Release Tablets and placebo for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSchizophrenia, Schizoaffective Disorder

CountriesUnited States

CollaboratorsNational Alliance for Research on Schizophrenia and Depression, Abbott

Timeline

Phase 4CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2006

First PostedMar 2006

Primary CompletionApr 2008

TodayJul 2026

First PostedMar 23, 2006

Enrollment StartMar 1, 2006

Primary CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 20.3 years ago

Interventions

Divalproex Sodium Extended-Release Tabletsdrug

divalproex sodium extended-release (ER) 1000 mg

placebodrug

placebo identical in appearance to active comparator