NCT01724372撤回不适用
The Role of Antidepressants or Antipsychotics in Preventing Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Attenuated positive, negative and general psychiatric symptoms
研究概览
简要总结
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.
Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-25 years of age (inclusive)
- •Able to understand and speak English
- •Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe
排除标准
- •Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
- •Current psychosis
- •Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
- •Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
- •Current stimulant treatment
- •Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
- •Estimated intelligence quotient < 70
研究组 & 干预措施
Antidepressant
Experimental
Fluoxetine
干预措施: Antidepressant (Drug)
Antipsychotic
Active Comparator
Aripiprazole
干预措施: Antipsychotic (Drug)
结局指标
主要结局
Attenuated positive, negative and general psychiatric symptoms
时间窗: 6 months
To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
次要结局
- Social and role functioning(6 months)
- Time to all-cause discontinuation.(6 months)
- Adverse effects(6 months)
研究者
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