Phase 4
Completed N=60
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)?
Source: ClinicalTrials.gov NCT00306475 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB) — 14.1; 14.3 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB) |
14.1; 14.3 | — |
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00306475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.