A Comparison of Long-Acting Injectable Medications for Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 22
- 主要终点
- Efficacy Failure
研究概览
简要总结
The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).
详细描述
The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule.
This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria
- •Age 18-65 years
- •Capacity to provide informed consent
- •Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate
- •Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.
排除标准
- •Patients who are currently stable and doing well on an antipsychotic regimen
- •Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol
- •Patients with tardive dyskinesia that is moderate or severe
- •Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study
- •Women who are pregnant or breastfeeding
- •Patients with mental retardation
研究组 & 干预措施
Paliperidone palmitate
Intramuscular injections of paliperidone palmitate 39-234 mg every month
干预措施: paliperidone palmitate (Drug)
Haloperidol decanoate
Intramuscular injections of haloperidol decanoate 25-200 mg every month
干预措施: haloperidol decanoate (Drug)
结局指标
主要结局
Efficacy Failure
时间窗: 24 months
Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
次要结局
- Changes in Psychiatric Symptoms(Baseline to 6 months)