Valproate in Late Life Schizophrenia

Overview

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.

Full Title of Study: “Add-on Valproate in Late Life Schizophrenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2006

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.

Interventions

  • Drug: Valproate
    • Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.

Arms, Groups and Cohorts

  • Experimental: valproate
    • All participants received open-label, add-on valproate.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Secondary Measures

  • Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible overall scores are 31 and 0 units on a scale, respectively.
  • Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.
  • Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.
  • Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.
  • Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.
  • Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible overall scores are 0 and 28 units on a scale, respectively.
  • Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)
    • Time Frame: Baseline to 12 weeks
    • The best and worst possible overall scores are 40 and 0 units on a scale, respectively.
  • Tolerability as Assessed by Weight Change
    • Time Frame: Baseline to 12 weeks
  • Tolerability as Measured by Mean Serum Level at Study Endpoint
    • Time Frame: Baseline to 12 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospitals Cleveland Medical Center
  • Collaborator
    • Abbott
  • Provider of Information About this Clinical Study
    • Martha Sajatovic MD, Case Western Reserve University
  • Overall Official(s)
    • Martha Sajatovic, MD, Principal Investigator, Case Western Reserve University School of Medicine

Citations Reporting on Results

Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Adjunct extended-release valproate semisodium in late life schizophrenia. Int J Geriatr Psychiatry. 2008 Feb;23(2):142-7. doi: 10.1002/gps.1854.

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