Adjunctive Aripiprazole in the Treatment of Risperidone-Induced Hyperprolactinemia: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prolactin level
研究概览
简要总结
Hyperprolactinemia is a frequent consequence of treatment with typical antipsychotic agents and atypical antipsychotics such as risperidone. Recent studies have suggested that aripiprazole, a partial dopamine agonist, reduces the prolactin response to antipsychotics. Thus, we conducted this study to evaluate the dose effects of adjunctive treatment with aripiprazole on hyperprolactinemia in stable schizophrenic patients maintained with risperidone.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-45 years of and fulfilled Diagnostic and Statistical Manual of Mental Disorders(DSM-IV )criteria (American Psychiatric Association, 1994) for schizophrenia;
- •having a stable psychiatric condition, defined as taking the same dosage of risperidone for at least 6 weeks;
- •being treated with risperidone monotherapy; and presence of hyperprolactinemia associated with risperidone.
排除标准
- •any other major psychiatric disorder;
- •significant concurrent medical illnesses, organic brain disorder, history of substance and alcohol abuse, and mental retardation
研究组 & 干预措施
aripiprazole 20mg
risperidone plus aripiprazole 20mg/day
干预措施: Aripiprazole (Drug)
aripiprazole 5mg
risperidone treatment plus aripiprazole 5mg/day
干预措施: Aripiprazole (Drug)
aripiprazole 10mg
risperidone plus aripiprazole 10mg/day
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Prolactin level
时间窗: baseline, 2 weeks, 4 weeks, 8 weeks
Change from baseline in the levels of prolactin
次要结局
- PANSS (positive and negative syndrome scale) score(Baseline, 8 weeks)
研究者
Jingxu Chen
associate professor
Beijing HuiLongGuan Hospital