Valproate in Late Life Schizophrenia - Full Text View

Sponsor:	University Hospitals of Cleveland
Collaborator:	Abbott
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00194025

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Valproate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Add-on Valproate in Late Life Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Positive and Negative Symptom Scale (PANSS) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Geriatric Depression Scale (GDS) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Chemistry panel - baseline and week 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Lipid profile - baseline and week 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
CBC with differential - baseline and week 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Valproate serum levels - weeks 2, 4, 8, and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Barnes Akathisia Scale - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Simpson Angus Neurological Rating Scale - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognitive status as measured by the Mini-mental state examination (MMSE) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Overall functioning as measured by the Global Assessment Scale (GAS) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
General health status as measure by the Short form 36 Health Survey (SF-36) - Baseline and weeks 2, 4, 8, and 12/study end [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	November 2004
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

Assigned Interventions

1: Experimental

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.

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194025

Locations

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

Sponsors and Collaborators

University Hospitals of Cleveland

Abbott

Investigators

Principal Investigator:

Martha Sajatovic, MD

Case Western Reserve University School of Medicine

More Information

Publications:

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.

Responsible Party:	Case Western Reserve University ( Martha Sajatovic MD )
Study ID Numbers:	10850-01-L0348
Study First Received:	September 13, 2005
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00194025 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Schizophrenia
Anticonvulsants
Valproic Acid
Valproate

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Valproic Acid

Pharmacologic Actions
Schizophrenia
Mental Disorders
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010