Valproate in Late Life Schizophrenia

December 16, 2014 updated by: University Hospitals Cleveland Medical Center

Add-on Valproate in Late Life Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: valproate
All participants received open-label, add-on valproate.
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.
Other Names:
  • Depakote
  • Depakote ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
Tolerability as Assessed by Weight Change
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks
Tolerability as Measured by Mean Serum Level at Study Endpoint
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10850-01-L0348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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