Effect of Nicotine Agonist Galantamine Added to High Potency Medications for Cognitive Function in Patients With Schizophrenia and Schizoaffective Disorder
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
- Improvement from baseline in performance on the cognitive battery: Stroop, Cornblatt CPT-IP, CDR Battery, letter number span, Grooved peg board, Tower of London, and Signal Detection Task.
研究概览
简要总结
This study is a double-blind, placebo-controlled trial of the nicotinic receptor agonist, galantamine, for the improvement of memory and attention in people with schizophrenia and schizoaffective disorder. Twenty subjects on a stable dose of antipsychotic medications receive galantamine or identical placebo tablets for 8 weeks. Adverse events are screened for every week. Tests of memory, attention, and reward responsivity are performed at baseline and afer 8 weeks on medication. Clinical scales rating psychiatric symptoms are performed at the beginning, middle, and end of the trial.
详细描述
Background:
Galantamine is a novel acetylcholinesterase inhibitor that is also a positive allosteric modulator of nicotinic acetylcholine receptors. Galantamine has been shown to increase conductivity of nicotinic receptors through a binding site that is discreet from the acetylcholine receptor. There is minimal risk of overstimulation with positive allosteric modulators as they do not produce receptor depolarization but potentiate submaximal acetylcholine induced depolarization. Our hypothesis is that allosteric modulation of nicotinic acetylcholine receptors is a potentially important treatment strategy in schizophrenia. We propose a trial of galantamine augmentation of antipsychotic medication in the treatment of schizophrenia to test the following hypotheses.
Hypotheses:
- Galantamine augmentation of antipsychotic treatment will be associated with improvement from baseline in performance on the cognitive battery: Stroop, Cornblatt CPT-IP, CDR Battery, letter number span, Grooved peg board, Tower of London, and Signal Detection Task.
- Galantamine augmentation of high potency antipsychotic treatment will be well tolerated and associated with improvement from baseline in negative symptoms (SANS), depressive symptoms (CDSS) and impulsivity (PANSS aggression item).
Study Design:
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
- Double
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder depressed type with stable psychiatric symptoms, no active suicidal ideation
- •Age 18-60, inclusive
- •Stable medical conditions such as hypertension, non-insulin-dependent diabetes, hypothyroidism allowed
- •Treated with antipsychotic medications at a stable dose for > 4 weeks
- •Not treated with investigational medications in the past 30 days
- •Competent to provide informed consent
- •WRAT-3 IQ raw score greater than or equal to 35
- •Expired CO level < 9 ppm
- •Salivary cotinine level < 30 ng/ml
- •Non-smoker for at least 3 months
排除标准
- •Diagnosis of dementia, neurodegenerative disease or any other current Axis I DSM-IV diagnosis
- •Any unstable medical illness, asthma requiring daily treatment, severe COPD, active peptic ulcer disease, gastrointestinal bleeding, atrioventricular block, urinary outflow obstruction, history of epilepsy
- •Concurrent use of anticholinergic medications or use of cholinomimetic medications in the past month, such as cogentin, donepezil or clozapine
- •Alcohol or substance abuse in the past month (self-report and confirmed by chart)
- •Known allergy or hypersensitivity to galantamine
- •Current treatment with erythromycin or ketoconazole
- •Concurrent use of NSAIDs
- •Women of childbearing potential
- •History of suicide attempt in the past year
结局指标
主要结局
Improvement from baseline in performance on the cognitive battery: Stroop, Cornblatt CPT-IP, CDR Battery, letter number span, Grooved peg board, Tower of London, and Signal Detection Task.
次要结局
- Improvement from baseline in negative symptoms (SANS), depressive symptoms (CDSS) and impulsivity (PANSS aggression item).