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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE January 26, 2009
Results First Posted Date  ICMJE March 1, 2011
Last Update Posted Date January 6, 2015
Study Start Date  ICMJE November 2004
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Efficacy:
  • Positive and Negative Symptom Scale (PANSS) - Baseline and weeks 2, 4, 8, and 12/study end
  • Geriatric Depression Scale (GDS) - Baseline and weeks 2, 4, 8, and 12/study end
  • Clinical Global Impression (CGI) - Baseline and weeks 2, 4, 8, and 12/study end
  • Tolerability:
  • Chemistry panel - baseline and week 12/study end
  • Lipid profile - baseline and week 12/study end
  • CBC with differential - baseline and week 12/study end
  • Valproate serum levels - weeks 2, 4, 8, and 12
  • Abnormal Involuntary Movement Scale (AIMS) - Baseline and weeks 2, 4, 8, and 12/study end
  • Barnes Akathisia Scale - Baseline and weeks 2, 4, 8, and 12/study end
  • Simpson Angus Neurological Rating Scale - Baseline and weeks 2, 4, 8, and 12/study end
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Tolerability as Assessed by Weight Change [ Time Frame: Baseline to 12 weeks ]
  • Tolerability as Measured by Mean Serum Level at Study Endpoint [ Time Frame: Baseline to 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Cognitive status as measured by the Mini-mental state examination (MMSE) - Baseline and weeks 2, 4, 8, and 12/study end
  • Overall functioning as measured by the Global Assessment Scale (GAS) - Baseline and weeks 2, 4, 8, and 12/study end
  • General health status as measure by the Short form 36 Health Survey (SF-36) - Baseline and weeks 2, 4, 8, and 12/study end
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproate in Late Life Schizophrenia
Official Title  ICMJE Add-on Valproate in Late Life Schizophrenia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: valproate
All participants received open-label, add-on valproate.
Intervention: Drug: Valproate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194025
Other Study ID Numbers  ICMJE 10850-01-L0348
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martha Sajatovic MD, Case Western Reserve University
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Abbott
Investigators  ICMJE
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
PRS Account University Hospitals Cleveland Medical Center
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP