NCT00337662已完成4 期
Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
研究概览
简要总结
The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
- •Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
- •Patients in whom a switch to another antipsychotic medication is acutely indicated.
排除标准
- •Patients who are deemed nonresponsive to risperidone or olanzapine.
- •Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit
- •Patients having received olanzapine or risperidone in the past 30 days.
- •Treatment with clozapine within 1 year prior to Visit
- •Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
- •A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.
研究组 & 干预措施
1
Experimental
Olanzapine for Not Early Onset response (NEO) patients
干预措施: olanzapine (Drug)
2
Active Comparator
Risperidone for Not Early Onset response (NEO) patients
干预措施: risperidone (Drug)
3
Active Comparator
Risperidone for Early Onset response (EO) patients
干预措施: risperidone (Drug)
结局指标
主要结局
Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
时间窗: Weeks 0, 3, 4, 6, 8, 12
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).
次要结局
- Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients(Weeks 2, 3, 4, 6, 8, 12)
- The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score(Week 0 to Week 12)
- The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score(Week 0 to Week 12)
- Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission(Week 0 to Week 12)
- Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission(Week 2 to Week 12)
- Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups(Week 2 to Week 12)
- Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index(Week 2 to Week 12)
- Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants(Week 2 to Week 12)
- Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale(Week 2 to Week 12)
- Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score(Week 2 to Week 12)
- Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score(Week 2 to Week 12)
- Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate(Week 2 and Week 12)
- Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure(Week 2 and Week 12)
- Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure(Week 2 and Week 12)
- Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate(Week 2 and Week 12)
- Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure(Week 2 and Week 12)
- Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight(Week 2 and Week 12)
研究者
研究点 (1)
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