An Open-Label, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
研究概览
简要总结
The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.
详细描述
This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.
The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.
Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.
The total duration of the study will be approximately 148 days.
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
- •Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Version IV
- •Dissatisfied with current medication (Medication Satisfaction Questionnaire score of less than or equal to 4) or by clinician's judgment and who may benefit from switching medication
- •Have received an oral antipsychotic for at least 4 weeks before randomization
- •Agrees to protocol-defined use of effective contraception
排除标准
- •History of neuroleptic malignant syndrome
- •Presence of congenital prolongation of the QT interval - History of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days
- •Any relevant medical history or current presence of systemic disease
- •Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
研究组 & 干预措施
Group 1 (Immediate switch)
Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase.
干预措施: Paliperidone palmitate (Drug)
Group 2 (Delayed switch)
Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered.
干预措施: Paliperidone palmitate (Drug)
结局指标
主要结局
Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
时间窗: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied.
次要结局
- Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)(Baseline, Week 8, and Week 21)
- Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale(Baseline, Week 8, and Week 21)
- Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)(Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21)
- Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale(Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21)
- Score of Mediation Adherence Rating Scale (MARS)(Baseline)