Add-on Valproate in Late Life Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •A primary psychiatric DSM Axis I diagnosis other than schizophrenia
- •Actively abusing substances; or
- •Medically unstable.
研究组 & 干预措施
valproate
All participants received open-label, add-on valproate.
干预措施: Valproate (Drug)
结局指标
主要结局
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)
时间窗: Baseline to 12 weeks
The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.
次要结局
- Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)(Baseline to 12 weeks)
- Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)(Baseline to 12 weeks)
- 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)
- 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)
- 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)
- Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)(Baseline to 12 weeks)
- 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)