Valproate in Late Life Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia

Interventions: Drug: Valproate

Registration Number: NCT00194025

Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
valproate	Valproate	All participants received open-label, add-on valproate.

Primary Outcome Measures

Name	Time	Method
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)	Baseline to 12 weeks	The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)	Baseline to 12 weeks	The best and worst possible overall scores are 31 and 0 units on a scale, respectively.
Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)	Baseline to 12 weeks	The best and worst possible GDS scores are 0 and 30 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)	Baseline to 12 weeks	The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.
Tolerability as Measured by Mean Serum Level at Study Endpoint	Baseline to 12 weeks
Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)	Baseline to 12 weeks	The best and worst possible overall scores are 40 and 0 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)	Baseline to 12 weeks	The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.
Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)	Baseline to 12 weeks	The best and worst possible overall scores are 0 and 28 units on a scale, respectively.
Tolerability as Assessed by Weight Change	Baseline to 12 weeks
Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)	Baseline to 12 weeks	The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.