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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)?

NCT00306475 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-27

Study results available
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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.

Conditions

Interventions

DRUG

Divalproex Sodium Extended-Release Tablets

divalproex sodium extended-release (ER) 1000 mg

DRUG

placebo

placebo identical in appearance to active comparator

Sponsors & Collaborators

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • Abbott

    collaborator INDUSTRY

  • Northwestern University

    lead OTHER

Principal Investigators

  • Stefania Bonaccorso, M.D. · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00306475 on ClinicalTrials.gov