A Molecular Approach to Treat Cognition in Schizophrenia: Ca2+ Channel Blockade
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures
研究概览
简要总结
The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.
详细描述
The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder. Incomplete treatment response can be common in these disorders. While there are medications that are effective at treating positive symptoms, some other symptoms of the disorders are often left only partially treated (cognitive impairment and negative symptoms). This study will begin to address if the medication isradipine might help to treat some of the cognitive problems associated with schizophrenia and schizoaffective disorder. Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel. It is currently approved by the FDA for hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •DSM-IV schizophrenia or schizoaffective disorder diagnosis
- •Residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the Brief Psychiatric Rating Scale (BPRS) hallucinatory behavior, unusual thought content, conceptual disorganization items
- •Hamilton Rating Scale for Depression (HRSD) equal to or less than 12
- •Baseline Clinician Administered Scale for Mania (CARS-M) score of less than 5
- •Simpson Angus Scale (SAS) total score equal to or less than 6
- •Treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period
排除标准
- •History of CNS trauma, neurological disorder, ADHD, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment
- •DSM-IV diagnosis of substance abuse/dependence within 3 months
- •Pregnant women or women of childbearing age who are not using a medically accepted means of contraception
- •Women who are breastfeeding
- •Active, unstable medical problem that may interfere with cognition
- •Current treatment for hypertension
- •Uncontrolled hypertension
- •Any drug known to interact with isradipine
- •History of GI strictures
- •History of heart disease
- •Abnormal lab or ECG at screen
- •Significant suicidal ideation at baseline (HRSD item 3>2)
- •ECT treatment within 12 months
研究组 & 干预措施
isradipine
open label
干预措施: isradipine (Drug)
结局指标
主要结局
MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures
时间窗: baseline and week 4
MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. A t score is a type of standard score computed by multiplying a z-score (how many standard deviations an element is from the mean) by 10 and adding 50.
UPSA Communication Score
时间窗: baseline and week 4
UCSD Performance Skills Assessment (UPSA) - The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for the communication subscale (range = 0-20), with higher score indicating better neurocognitive functioning
Quality of Life (QoL) Scale
时间窗: baseline and Week 4
The QoL is a measure of the perceived satisfaction in an individual's daily life. This 16-item self-report measure is rated on a 7-point scale, ranging from 1 (terrible) to 7 (delighted), with a total score range from 16-112, where higher scores indicate higher satisfaction with daily life.
次要结局
- Number of Participants With Normal Complete Blood Count (CBC)(baseline and week 4)
- Mean Change in PRISE Adverse Event Checklist Score(up to 4 weeks)
- Number of Participants With Normal ECG(baseline and week 4)
- Clinician Administered Rating Scale for Mania (CARS-M)(up to 4 weeks)
- Number of Participants With Normal Chemistry Panel(baseline and week 4)
- Hamilton Rating Scale for Depression (HRSD)(up to 4 weeks)
- Abnormal Involuntary Movement Scale (AIMS)(baseline and Week 4)
- Beck Scale for Suicidal Ideation (SSI)(up to 4 weeks)
- Number of Participants With Suicidal Acknowledgments(up to 4 weeks)
- Number of Participants With a Confirmed SCID-IV(baseline)
- Clinical Global Impression Scale (CGI)(up to 4 weeks)
- Modified Simpson Angus Scale (MSAS)(baseline and week 4)
- Brief Psychiatric Rating Scale (BPRS)(up to 4 weeks)
- Scale for the Assessment of Negative Symptoms (SANS)(up to 4 weeks)
研究者
Katherine Burdick
Principal Investigator
Icahn School of Medicine at Mount Sinai