Valproate in Late Life Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Valproate (Drug)

Phase: Phase 4

Status: Completed

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 have schizophrenia.

Official title: Add-on Valproate in Late Life Schizophrenia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Efficacy:

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

Tolerability:

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

Secondary outcome:

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

Detailed description: 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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- A primary psychiatric DSM Axis I diagnosis other than schizophrenia

- Actively abusing substances; or

- Medically unstable.

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Starting date: November 2004
Ending date: November 2006
Last updated: February 12, 2008