A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor speed, and executive function.
研究概览
简要总结
The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of sildenafil 50 & 100 mg added to stable antipsychotic treatment in schizophrenia patients to assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory, fluency, attention, spatial memory, motor speed, and executive function) and clinical symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).
详细描述
Specific Aims:
- Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor speed, and executive function.
- Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.
- Assess self-reports of side effects of sildenafil 50 & 100 mg.
Location and Subjects:
25 adult outpatients with schizophrenia will be recruited from the Massachusetts General Hospital outpatient clinic or the Freedom Trail Clinic of the Lindemann Center. All research procedures will be performed at the Psychopharmacology Clinic of the Massachusetts General Hospital. Subjects must be English speaking because the cognitive battery has only been validated in English.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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.
- •Age 18-65 years
- •Male or female
- •Clinically stable without a medication change within 4 weeks
- •Able to complete cognitive testing (must be English-speaking)
- •Willing to use appropriate birth control during study participation (if female)
排除标准
- •Active substance abuse or dependence
- •PDE 5 inhibitor taken within 24 hours of study drug
- •Currently taking a drug that inhibits hepatic cytochrome P450 3A4 (eg. Nefazadone, fluvoxamine, erythromycin, ketoconazole, itraconazole, cimetidine, saquinavir, ritonavir, St. John's wort, or grapefruit juice).
- •Currently taking drugs that induce P45 3A4 (eg. phenytoin, carbamezapine, Phenobarbital, rifampin)
- •Unstable medical disease
- •Significant cardiac disease
- •Bleeding disorder
- •Peptic ulcer disease
- •Hepatic impairment
- •Moderate or greater renal impairment
- •History of migraines
- •Currently taking nitrates or alpha blockers
- •Resting blood pressure < 90/50 or >140/90 mm.
- •History of intolerance to PDE5 inhibitors
- •History of inappropriate sexual behavior (eg, masturbation in public, stalking, assault)
- •History of priapism
- •Pregnant or lactating
结局指标
主要结局
Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor speed, and executive function.
时间窗: 12 days
次要结局
- Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on psychotic, negative, and mood symptoms.(12 days)
- Side effects of sildenafil 50 & 100 mg as self-reported by subjects and as measured with vital signs.(12 days)