Valproate in Late Life Schizophrenia
Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Valproate (Drug)
Phase: Phase 4
Sponsored by: University Hospitals of Cleveland
Official(s) and/or principal investigator(s):
Martha Sajatovic, MD, Principal Investigator, Affiliation: Case Western Reserve University School of Medicine
The purpose of this research study is to analyze the effectiveness and tolerability of a
medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who
Official title: Add-on Valproate in Late Life Schizophrenia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Positive and Negative Symptom Scale (PANSS) - Baseline and weeks 2, 4, 8, and 12/study end
Geriatric Depression Scale (GDS) - Baseline and weeks 2, 4, 8, and 12/study end
Clinical Global Impression (CGI) - Baseline and weeks 2, 4, 8, and 12/study end
Chemistry panel - baseline and week 12/study end
Lipid profile - baseline and week 12/study end
CBC with differential - baseline and week 12/study end
Valproate serum levels - weeks 2, 4, 8, and 12
Abnormal Involuntary Movement Scale (AIMS) - Baseline and weeks 2, 4, 8, and 12/study end
Barnes Akathisia Scale - Baseline and weeks 2, 4, 8, and 12/study end
Simpson Angus Neurological Rating Scale - Baseline and weeks 2, 4, 8, and 12/study end
Cognitive status as measured by the Mini-mental state examination (MMSE) - Baseline and weeks 2, 4, 8, and 12/study end
Overall functioning as measured by the Global Assessment Scale (GAS) - Baseline and weeks 2, 4, 8, and 12/study end
General health status as measure by the Short form 36 Health Survey (SF-36) - Baseline and weeks 2, 4, 8, and 12/study end
It is known that up to 30% of individuals with schizophrenia continue to have symptoms even
when treated with current FDA-approved medications intended to treat their schizophrenia.
Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be
effective for related conditions such as bipolar disorder (manic depressive illness), and are
also used by some physicians in clinical settings in combination with antipsychotic
medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are
approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will
test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when
added to antipsychotic medications.
Minimum age: 50 Years.
Maximum age: N/A.
- Must have a diagnosis of schizophrenia as confirmed by the MINI
- Must be on antipsychotic medication
- Must be age 50 year or older
- Must be capable of providing written informed consent for study participation. In
situations where individuals have guardians of person, guardian and subject must both
provide written consent; and
- Must live in the Northeast Ohio area.
- A primary psychiatric DSM Axis I diagnosis other than schizophrenia
- Actively abusing substances; or
- Medically unstable.
Locations and Contacts
University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Starting date: November 2004
Ending date: November 2006
Last updated: February 12, 2008