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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Secondary Outcome Measures:

Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Tolerability as Measured by Mean Serum Level at Study Endpoint [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]

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
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

Arms

Assigned Interventions

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

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:	Martha Sajatovic MD, Case Western Reserve University
ClinicalTrials.gov Identifier:	NCT00194025 History of Changes
Other Study ID Numbers:	10850-01-L0348
Study First Received:	September 13, 2005
Results First Received:	January 26, 2009
Last Updated:	March 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Schizophrenia
Anticonvulsants
Valproic Acid
Valproate

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012