NCT00194025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 1, 2011

Completed
Last Updated

January 6, 2015

Status Verified

February 1, 2011

Enrollment Period

2 years

First QC Date

September 13, 2005

Results QC Date

January 26, 2009

Last Update Submit

December 16, 2014

Conditions

Schizophrenia

Keywords

SchizophreniaAnticonvulsantsValproic AcidValproate

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 12 weeks

Secondary Outcomes (9)

  • Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)

    Baseline to 12 weeks

  • Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)

    Baseline to 12 weeks

  • Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)

    Baseline to 12 weeks

  • Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)

    Baseline to 12 weeks

  • Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)

    Baseline to 12 weeks

  • +4 more secondary outcomes

Study Arms (1)

valproate

EXPERIMENTAL

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

Drug: Valproate

Interventions

ValproateDRUG

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.

Also known as: Depakote, Depakote ER
valproate

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • A primary psychiatric DSM Axis I diagnosis other than schizophrenia
  • Actively abusing substances; or
  • Medically unstable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 17582828RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Limitations and Caveats

The findings of this study must be interpreted cautiously given the limitations of small sample size, open-label, add-on design and lack of a control or comparator group. The mean age of 61 years is not representative of the "old-old" populations.

Results Point of Contact

Title
Martha Sajatovic MD
Organization
Case Western Reserve University and Unversity Hospitals Case Medical Center
martha.sajatovic@uhhospitals.org
216-844-2808

Study Officials

  • Martha Sajatovic, MD

    Case Western Reserve University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 6, 2015

Results First Posted

March 1, 2011

Record last verified: 2011-02

Locations

US(1)