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| Sponsor: | University Hospitals of Cleveland |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | University Hospitals of Cleveland |
| ClinicalTrials.gov Identifier: | NCT00194025 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Valproate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Add-on Valproate in Late Life Schizophrenia |
| Enrollment: | 20 |
| Study Start Date: | November 2004 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Valproate
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.
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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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: | Martha Sajatovic, MD | Case Western Reserve University School of Medicine |
More Information
| Responsible Party: | Case Western Reserve University ( Martha Sajatovic MD ) |
| Study ID Numbers: | 10850-01-L0348 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00194025 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Schizophrenia Anticonvulsants Valproic Acid Valproate |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Valproic Acid |
Pharmacologic Actions Schizophrenia Mental Disorders Therapeutic Uses GABA Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features Anticonvulsants |