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Valproate in Late Life Schizophrenia

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ClinicalTrials.gov Identifier: NCT00194025
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 1, 2011
Last Update Posted : January 6, 2015
Sponsor:
Collaborator:
Abbott
Information provided by:
University Hospitals Cleveland Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Valproate Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Add-on Valproate in Late Life Schizophrenia
Study Start Date : November 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Tolerability as Assessed by Weight Change [ Time Frame: Baseline to 12 weeks ]
  9. Tolerability as Measured by Mean Serum Level at Study Endpoint [ Time Frame: Baseline to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194025


Locations
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United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Abbott
Investigators
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Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
More Information
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Publications of Results:

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Responsible Party: Martha Sajatovic MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00194025    
Other Study ID Numbers: 10850-01-L0348
First Posted: September 19, 2005    Key Record Dates
Results First Posted: March 1, 2011
Last Update Posted: January 6, 2015
Last Verified: February 2011
Keywords provided by University Hospitals Cleveland Medical Center:
Schizophrenia
Anticonvulsants
Valproic Acid
Valproate
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
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