The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Time to Treatment Failure
研究概览
简要总结
We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.
详细描述
To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •consent obtained from patients and their parents (assent for patients under 18);
- •age 12-25 years (inclusive);
- •English-speaking;
- •at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.
排除标准
- •lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
- •current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
- •current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
- •current stimulant treatment;
- •history of neurological, neuroendocrine or other medical condition known to affect the brain;
- •any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
- •past or current substance dependence; sunstance abuse within the last 4 weeks;
- •IQ < 70.
研究组 & 干预措施
Aripiprazole
To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg).
干预措施: Aripiprazole (Drug)
Fluoxetine
To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg).
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Time to Treatment Failure
时间窗: 24 weeks
Time to either all-cause-discontinuation or need to add another psychotropic agent
次要结局
- Change in Prodromal Symptoms (SOPS) Total Scores(24 weeks)
- Change in Social and Role Functioning Scores(24 weeks)
- Number of Patients With Specific Adverse Effects(24 weeks)
- Subjective Well-being Questionnaire(24 weeks)
研究者
Christoph U. Correll, MD
Professor of Psychiatry and Molecular Medicine Hofstra North Shore LIJ School of Medicine
Northwell Health