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Valproate in Late Life Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Valproate
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Anticonvulsants, Valproic Acid, Valproate

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals of Cleveland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

valproate

Arm Description

All participants received open-label, add-on valproate.

Outcomes

Primary Outcome Measures

Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
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)
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)
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)
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)
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)
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)
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)
The best and worst possible overall scores are 40 and 0 units on a scale, respectively.
Tolerability as Assessed by Weight Change
Tolerability as Measured by Mean Serum Level at Study Endpoint

Full Information

First Posted
September 13, 2005
Last Updated
December 16, 2014
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00194025
Brief Title
Valproate in Late Life Schizophrenia
Official Title
Add-on Valproate in Late Life Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Anticonvulsants, Valproic Acid, Valproate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
valproate
Arm Type
Experimental
Arm Description
All participants received open-label, add-on valproate.
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Depakote, Depakote ER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
Description
The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)
Description
The best and worst possible overall scores are 31 and 0 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)
Description
The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)
Description
The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)
Description
The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)
Description
The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)
Description
The best and worst possible overall scores are 0 and 28 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)
Description
The best and worst possible overall scores are 40 and 0 units on a scale, respectively.
Time Frame
Baseline to 12 weeks
Title
Tolerability as Assessed by Weight Change
Time Frame
Baseline to 12 weeks
Title
Tolerability as Measured by Mean Serum Level at Study Endpoint
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
Case Western Reserve University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17582828
Citation
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.
Results Reference
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Valproate in Late Life Schizophrenia

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