Clinical trial NCT00194025: Valproate in Late Life Schizophrenia
Official title: Add-on Valproate in Late Life Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Anticonvulsants
Valproic Acid
Valproate
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)
timeFrame: Baseline to 12 weeks
measure: Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)
timeFrame: Baseline to 12 weeks
measure: Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)
timeFrame: Baseline to 12 weeks
measure: Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)
timeFrame: Baseline to 12 weeks
measure: Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)
timeFrame: Baseline to 12 weeks
measure: Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline to 12 weeks
measure: Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)
timeFrame: Baseline to 12 weeks
measure: Tolerability as Assessed by Weight Change
timeFrame: Baseline to 12 weeks
measure: Tolerability as Measured by Mean Serum Level at Study Endpoint
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.