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)?

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00306475
• Date of registration: 22/03/2006
• Primary sponsor: Vanderbilt University
• Public title: 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)?
• Scientific title: 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)?
• Date of first enrolment: March 2006
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00306475
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Stefania Bonaccorso, M.D.
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion criteria

- Male or female, age 18-65

- 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizoaffective Disorder

Schizophrenia

Intervention(s)

Drug: divalproex sodium ER

Drug: placebo

Primary Outcome(s)

Improvements in cognition and psychopathology [Time Frame: six weeks]

Secondary ID(s)

051231

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott

National Alliance for Research on Schizophrenia and Depression