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| Sponsors and Collaborators: |
Vanderbilt University National Alliance for Research on Schizophrenia and Depression Abbott |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00306475 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: divalproex sodium ER Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official 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)? |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: divalproex sodium ER
divalproex sodium ER1000 mg
|
| 2: Placebo Comparator |
Drug: placebo
placebo identical in appearance to active comparator
|
Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations| United States, Tennessee | |
| Psychiatric Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37212 | |
| Principal Investigator: | Stefania Bonaccorso, M.D. | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Herbert Meltzer, M.D. ) |
| Study ID Numbers: | 051231 |
| Study First Received: | March 22, 2006 |
| Last Updated: | June 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00306475 |
| Health Authority: | United States: Institutional Review Board |
|
schizophrenia, cognition, mood stabilizer |
|
Schizophrenia Mental Disorders Psychotic Disorders Valproic Acid Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |
