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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)?

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Abbott
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00306475
First received: March 22, 2006
Last updated: January 6, 2010
Last verified: January 2010
History of Changes
  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 4

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
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)?

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Improvements in cognition and psychopathology [ Time Frame: six weeks ] [ Designated as safety issue: No ]

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
Active Comparator: 1 Drug: divalproex sodium ER
divalproex sodium ER1000 mg
Placebo Comparator: 2 Drug: placebo
placebo identical in appearance to active comparator

Detailed Description:

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306475

Locations
United States, Tennessee
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
National Alliance for Research on Schizophrenia and Depression
Abbott
Investigators
Principal Investigator: Stefania Bonaccorso, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00306475     History of Changes
Other Study ID Numbers: 051231
Study First Received: March 22, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
schizophrenia, cognition, mood stabilizer

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Valproic Acid
Antipsychotic Agents
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013