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Valproate in Late Life Schizophrenia

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Completed
Phase 4

Conditions

Schizophrenia

Treatments

Drug: Valproate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00194025
10850-01-L0348

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

valproate
Experimental group
Description:
All participants received open-label, add-on valproate.
Treatment:
Drug: Valproate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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