Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Score on attenuated positive symptom scale at 16 weeks
研究概览
简要总结
The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.
详细描述
Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are between the ages of 12 and
- •Participants are English-speaking.
- •Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- •Participants meet additional RAP criteria (evaluated during screening and interview).
排除标准
- •Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
- •Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- •Participants have a medical condition that contraindicates treatment with sertraline or risperidone.
- •Participants have past or current substance dependence.
- •Participants are currently taking and responding well to antidepressant or antipsychotic medication
结局指标
主要结局
Score on attenuated positive symptom scale at 16 weeks
Score on attenuated negative symptom scale at 16 weeks
次要结局
- Score on social functioning measure at 16 weeks
- Score on academic functioning measure at 16 weeks
- Score on cognitive measures at 16 weeks