Open-Label Study of Aripiprazole in Individuals at Risk for Chronic Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Score on attenuated positive symptom scale at 12 weeks
研究概览
简要总结
The RAP Program is conducting a research study of the antipsychotic medication Aripiprazole. This drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. This study will explore how well Aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.
详细描述
During the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. These visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. Monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. Participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. Depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are between the ages of 13 and
- •You are English-speaking.
- •You have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder
- •You are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- •You meet additional RAP criteria assessed during screening and interview.
排除标准
- •You have a diagnosis of bipolar disorder or major depression with psychotic features.
- •You have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- •You have past or current substance dependence.
- •You are currently taking Aripiprazole.
- •You have taken Aripiprazole in the past.
- •You are currently taking and responding well to another medication.
结局指标
主要结局
Score on attenuated positive symptom scale at 12 weeks
Score on attenuated negative symptom scale at 12 weeks
Score on adverse events rating scale at 12 weeks
次要结局
- Score on social functioning scale at 12 weeks
- Score on academic functioning scale at 12 weeks
- Score on cognitive measures at 12 weeks