Serotonin 1A Agonists and Cognition in Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- This study will examine the effect on cognition of the addition of buspirone compared with addition of a sugar pill to patients treated with olanzapine or risperidone
研究概览
简要总结
Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. Patients will be assigned to take active medication (Buspar)or placebo along with their prescribed antipsychotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.
详细描述
Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.
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
- •Subjects must meet all of the following criteria to be eligible for participation in the current research study.
- •Subjects will be males and females between 18-65 years of age;
- •Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
- •The subjects or their legal guardian must sign the informed consent;
- •Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months
排除标准
- •Subjects who are pregnant or lactating
- •Subjects who have brain damage and/or neurological disorders
- •Subjects who have current substance dependence
- •Subjects unable to provide informed consent
研究组 & 干预措施
1
buspirone 15-30 mg qd
干预措施: adjunctive treatment with buspirone (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
This study will examine the effect on cognition of the addition of buspirone compared with addition of a sugar pill to patients treated with olanzapine or risperidone
时间窗: six weeks
次要结局
未报告次要终点
研究者
Herbert Meltzer
Professor
Vanderbilt University