An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 主要终点
- Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
研究概览
简要总结
The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)
详细描述
This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire [MSQ] <4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- •Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
- •Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
- •Competent patients who manage to answer the questionnaires
排除标准
- •Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- •Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
- •Had received two or more different kind of antipsychotics.
- •Had a history of taking paliperidone extended release (ER).
- •Allergy or hypersensitivity to risperidone or paliperidone ER.
- •Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
- •Have had Medication Satisfaction Questionnaire (MSQ) score>3
- •Have been hospitalized for longer than 8 continuous weeks during the past 6 months
- •Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
- •Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
研究组 & 干预措施
Paliperidone ER
Immediate initiation of Paliperidone ER for a total of 12 weeks
干预措施: Paliperdidone ER (Drug)
Antipsychotics and paliperidone ER
Delayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
干预措施: Paliperdidone ER (Drug)
Antipsychotics and paliperidone ER
Delayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
干预措施: Aripiprazole, olanzapine and risperidone (Antipsychotics) (Drug)
结局指标
主要结局
Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
时间窗: Baseline and Week 8
A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied
次要结局
- Drug Attitude Inventory (DAI)-10 Score(Baseline to Week 12)
- Clinical Global Impression-Severity (CGI-S) Score(Baseline to Week 12)
- Positive and negative symptoms scale (PANSS) score(Baseline to Week 12)
- Personal and Social Performance Scale (PSP)(Baseline to Week 12)
- Sleep Visual Analog Scale (Sleep VAS)(Baseline to Week 12)
- Number of patients with adverse events(Baseline to Week 12)
- Number of patients with vital signs and physical examination(Baseline to Week 12)
- Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride)(Baseline to Week 12)