Valproate in Late Life Schizophrenia
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Add-on Valproate in Late Life Schizophrenia |
- Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.
- Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible overall scores are 31 and 0 units on a scale, respectively.
- Change in Overall Functioning as Measured by the Global Assessment Scale (GAS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.
- Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible GDS scores are 0 and 30 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) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible MCS scores are 100 and 1 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) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.
- Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible overall scores are 0 and 28 units on a scale, respectively.
- Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]The best and worst possible overall scores are 40 and 0 units on a scale, respectively.
- Tolerability as Assessed by Weight Change [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]
- Tolerability as Measured by Mean Serum Level at Study Endpoint [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: valproate
All participants received open-label, add-on valproate.
|
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.
Other Names:
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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
Publications:
| Responsible Party: | Martha Sajatovic MD, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00194025 History of Changes |
| Other Study ID Numbers: | 10850-01-L0348 |
| Study First Received: | September 13, 2005 |
| Results First Received: | January 26, 2009 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University Hospitals of Cleveland:
|
Schizophrenia Anticonvulsants Valproic Acid Valproate |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Valproic Acid Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013