Effectiveness of Switching Antipsychotic Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 219
- 主要终点
- Number Who Discontinued Medication Within First 6 Study Months
研究概览
简要总结
This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
详细描述
Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.
Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCID diagnosis of schizophrenia or schizoaffective disorder
- •Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
- •Treatment with antipsychotic medications for at least 2 months
- •Received at least 1 outpatient mental health service every 3 months for the past 6 months
排除标准
- •Severe symptoms or side effects that indicate the necessity for a medication change
- •Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
- •Treatment with clozapine
- •One or more nights spent in a psychiatric hospitalization within the past 3 months
- •Received services from a crisis intervention program within the past 3 months
- •Require placement in a skilled nursing facility as a result of a physical condition or disability
- •Criminal charges pending (once charges clear, the person will be considered)
- •Pregnant or breast feeding
- •Contraindication to any of the medications to which the patient might be assigned
研究组 & 干预措施
Switch per study protocol
Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Ziprasidone (Drug)
Stay on baseline medication prescribed
Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Ziprasidone (Drug)
Stay on baseline medication prescribed
Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Risperidone (Drug)
Stay on baseline medication prescribed
Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Olanzapine (Drug)
Stay on baseline medication prescribed
Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Quetiapine (Drug)
Stay on baseline medication prescribed
Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Aripiprazole (Drug)
Switch per study protocol
Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Risperidone (Drug)
Switch per study protocol
Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Olanzapine (Drug)
Switch per study protocol
Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Quetiapine (Drug)
Switch per study protocol
Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Number Who Discontinued Medication Within First 6 Study Months
时间窗: Measured at Six Months
次要结局
- Psychiatric Symptoms, Hospitalization, and Medication Side Effects(Measured at Year 1)
研究者
Nancy Covell
Associate Director, CPI
Icahn School of Medicine at Mount Sinai