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Valproate in Late Life Schizophrenia

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Valproate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Martha Sajatovic, MD, Principal Investigator, Affiliation: Case Western Reserve University School of Medicine

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.

Clinical Details

Official title: Add-on Valproate in Late Life Schizophrenia

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)

Secondary outcome:

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

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

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

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

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

Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)

Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)

Tolerability as Assessed by Weight Change

Tolerability as Measured by Mean Serum Level at Study Endpoint

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Additional Information

Starting date: November 2004
Last updated: December 16, 2014

Page last updated: August 20, 2015

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