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 | Completed Phase 4 Results

• 1 other identifier: 051231
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia, cognition, mood stabilizer

Outcome Measures

Primary Outcomes (1)

• Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB)

  Giving Divalproex Sodium ER to Outpatients with Schizophrenia and Schizoaffective Disorder in addition to taking Atypical Antipsychotic Drug has shown to change their cognition and psychopathology. The MCCB measures cognitive function. The MCCB provides an overall composite score, expressed as a T-score, with a mean of 50 and a standard deviation of 10 The MCCB does not have minimum and maximum scores due to the use of T scores. A typical score will fall within a range of 40-60. Scores below 40 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities. The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.

  six weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Divalproex Sodium Extended-Release Tablets

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Divalproex Sodium Extended-Release Tablets DRUG

divalproex sodium extended-release (ER) 1000 mg

1

placebo DRUG

placebo identical in appearance to active comparator

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18-65
• Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
• Treated with olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone monotherapy for at least three months prior to enrollment
• Able to provide written consent

You may not qualify if:

• Primary DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
• Treatment with any antipsychotic other than olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone in the past three months
• Treatment with a mood stabilizer or an antidepressant continuously in the past three months. Patients who have had it for less than two weeks continuously will be permitted to enter.
• Pregnant or lactating females

Sponsors & Collaborators

• Northwestern University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Abbott: collaborator

Study Sites (1)

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Herbert Meltzer, M.D.
• Organization: Vanderbilt Psychiatric Hospital

herbert.meltzer@vanderbilt.edu

615-327-7049

Study Officials

• Stefania Bonaccorso, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2022-04

Locations

US (1)