A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
研究概览
简要总结
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.
详细描述
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.
- Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.
- Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS).
- Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.
- Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
- Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.
- Effect the variability of response in placebo and modafinil groups for each of the outcome measures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
- •Ages 18-65 years
- •Capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
- •Stable dose of clozapine for at least 1 month
- •Three months of stable psychotic symptoms
排除标准
- •Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
- •Current substance abuse
- •Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
- •Unable to complete neuropsychological tests
- •History of serious blood dyscrasia requiring discontinuation of clozapine
- •Serious suicidal or homicidal risk within the past six months
- •Current treatment with a psychostimulant
研究组 & 干预措施
modafinil
modafinil 100mg, 200mg, or 300mg (dose escalation)
干预措施: modafinil (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.
时间窗: 8 weeks
次要结局
- Effect the variability of response in placebo and modafinil groups for each of the outcome measures.(8 weeks)
- Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.(8 weeks)
- Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS).(8 weeks)
- Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.(8 Weeks)
- Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.(8 weeks)