Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- QOL measured by Korean version of Heinrich's Quality of Life Scale
研究概览
简要总结
The primary objective of this study is to demonstrate clinical and statistical superiority of quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale after 8 weeks trial of drugs.
详细描述
Prolactin related adverse events are closely related to patient's perception on their illness and quality of life . Poor subjective wellbeing induced by prolactin elevation after antipsychotic drug treatment can complicate the clinical outcomes of treatment.Quetiapine has negligible effects on the elevation of prolactin and does not produce hyperprolactinemia related adverse events such as amenorrhea, galactorrhea that may disturb quality of life in famel patient. In this Randomized, Open Label, 8-week Study, the impact of quetiapine and risperidone on quality of life in female patients with schizophrenia will be compared.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Schizophrenia (DSM-IV)
- •Female, Age: between 18-60 years
- •Who either need first time treatment with antipsychotic drug or recently
- •Sign written informed consent
排除标准
- •Taking other psychiatric medications during last 30 days
- •Refractory schizophrenia
- •A current medical illness associated with sexual dysfunction
- •Previous history of no response to quetiapine or risperidone treatment
- •Previous enrolment or randomisation of treatment in the present study.
- •Participation in a clinical study during the last 90 days.
- •Alcohol or substance abuser
结局指标
主要结局
QOL measured by Korean version of Heinrich's Quality of Life Scale
时间窗: 8weeks
次要结局
- Korean version of Female Sexual Function Index(8 weeks)
- Korean version of Female Sexual Distress Scale(8 weeks)
- Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH(8 weeks)
- Psychopathology (Brief Psychiatric Rating Scale)(8 weeks)