Treatment Satisfaction and Effectiveness of Lurasidone on Quality of Life and Functioning in Adult Patients With Schizophrenia Treated in the Real World Italian Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Patient's functioning & quality of life
研究概览
简要总结
The study is a multicentric, national, non-interventional, prospective, single arm study.
The main goal of this study is to gather information about the effects, in a real-life setting, of lurasidone treatment on patient's reported outcomes, in terms of patient's treatment satisfaction, Quality of Life and functioning changes after 6 weeks from lurasidone treatment initiation in schizophrenia patients naïve to lurasidone.
详细描述
Important aim of the study is to investigate, aspects related to effectiveness, safety and tolerability at 3 months' lurasidone treatment in a routine practice in Italian clinical settings.
Only patients with primary diagnosis of schizophrenia who are prescribed lurasidone was evaluated for inclusion in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years) male or female subjects;
- •Primary diagnosis of schizophrenia
- •Patients not previously treated with lurasidone. The choice to initiate lurasidone treatment is independent of being included in the study;
- •Patients legally capable of giving their written consent for participation in the study and for personal data processing.
排除标准
- •Concomitant participation in a clinical trial
研究组 & 干预措施
Lurasidone Treatment
Adult patients suffering from schizophrenia treated for 3 months with lurasidone according to routine clinical practice.
干预措施: Lurasidone (Drug)
结局指标
主要结局
Patient's functioning & quality of life
时间窗: 6 weeks after treatment
To assess the Patient's functioning and quality of life a Quality-of-Life Scale was used. Quality Life Scale is a standardized questionnaire that evaluates various aspects of an individual's life, interpersonal relation, instrumental role, Intrapsychic Foundations, Common Objects and Activities and overall satisfaction with life. The Quality of Life Scale is a validated measure of health-related quality of life and functioning in schizophrenia that focuses on intrapsychic, social, and negative symptoms and their impact on functioning in schizophrenia. The questionnaire consists of 21 items in 4 domains: Interpersonal Relations (8 items), Instrumental Role (4 items), Intrapsychic Foundations (7 items), and Common Objects and Activities (2 items). Each item is scored on a 7-point Likert scale ranging from 0 (severe impairment) to 6 (normal or unimpaired functioning). A score is calculated for each domain, and the total score ranges from 0 to 126.
Patient's and caregiver's treatment satisfaction- releif of symptoms
时间窗: 6 weeks after treatment
Patient's and caregiver's satisfaction is evaluated by Seven-point Likert scales derived from Treatment Satisfaction Questionnaire for Medication used to assess patient's and caregiver's satisfaction about efficacy, safety, usability and global impression of medications. Patient's satisfaction with efficacy, safety, ease of use, and overall impression of medication was measured using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. Caregiver's satisfaction with efficacy, safety, ease of use, and overall impact on patient management was assessed using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. The questionnaire consists of 4 items. Each item is scored on a 7-point Likert scale ranging from 1 (Extremely dissatisfied) to 7 (Extremely satisfied).
次要结局
- Patient's and caregiver's treatment satisfaction- releif of symptoms(3 months after treatment)
- Patient's functioning & quality of life(3 months after treatment)
- Evaluation of the weight gain, signs and symptoms of prolactinby by Investigator's Assessment Questionnaire(3 months after treatment)
- Evaluation of adverse drug reactions, akathisia, other extrapyramidal symptoms by Investigator's Assessment Questionnaire(3 months after treatment)
- Efficacy evaluation by Clinical global impression(3 months after treatment)
- Efficacy evaluation by Investigator's Assessment Questionnaire(3 months after treament)