Nicotinic Receptors and Schizophrenia: Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Neurocognitive Efficacy
研究概览
简要总结
The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
详细描述
Patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. If pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. Then patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. After one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be selected to be 18 to 65 years old and in good general health.
- •Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
- •Smokers will smoke at least 20 cigarettes per day.
- •Non-smokers will also be enrolled.
- •Subjects will have normal:
- •vital signs,
- •hematology,
- •serum chemistries,
- •urinalysis with a negative drug screen before entry into the study.
- •Subjects will be fluent in English.
- •Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.
排除标准
- •Subjects with histories of:
- •neurological illness,
- •liver disease,
- •severe hypertension (cut-off blood pressure 160/100) or
- •cardiac disease, or
- •renal failure (cut-off creatinine above 1.4).
- •Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
- •Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
- •Subjects being treated with Clozapine will be excluded.
研究组 & 干预措施
DMXB-A-SR
Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
干预措施: DMXB-A-SR (Drug)
Arm #2: Placebo Comparator
Inert capsule to resemble active drug.
干预措施: Placebo (Other)
结局指标
主要结局
Neurocognitive Efficacy
时间窗: 4 weeks
MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.
次要结局
- Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli(4 weeks)