A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Acceptance
研究概览
简要总结
The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder.
The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing
详细描述
The investigators will randomly assign 30 patients newly admitted to Central Regional Hospital (CRH) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to 14 days of treatment with either asenapine 5 mg BID or asenapine 10 mg QHS.
The investigators will assess patient and staff acceptance on day 14. The investigators will assess staff acceptance on day 14. The investigators will assess changes in psychopathology (Brief Psychiatric Rating Scale) from baseline to day 14.
The investigators propose to achieve the following specific aims:
- To compare the patient acceptance of once daily versus twice daily asenapine; The investigators hypothesize that patient acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
- To compare the staff (medication nurses) acceptance of once daily versus twice daily asenapine; the investigators hypothesize that staff acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14
- To compare the changes in psychopathology with once daily versus twice daily asenapine; the investigators hypothesize that changes in psychopathology from baseline to day 14 will be similar for the two dosing strategies
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
- None
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
- •Male or female individuals,
- •18-65 years of age,
- •who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder,
- •who are newly admitted to Central Regional Hospital for treatment of an acute psychotic exacerbation,
- •who provide signed informed consent to participate, will be included.
排除标准
- •Females who are lactating or pregnant,
- •individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded
研究组 & 干预措施
asenapine 10 mg daily in the evening
Patients will receive their entire daily dose of asenapine as a single dose in the evening
干预措施: Asenapine 10 mg daily in the evening (Drug)
asenapine 5 mg twice daily
Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
干预措施: Asenapine 5 mg twice daily (Drug)
结局指标
主要结局
Patient Acceptance
时间窗: At day 14
A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.
次要结局
- Change in Brief Psychiatric Rating Scale (BPRS) Total Score(From baseline to day 14)