Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 18
- 主要终点
- Change in the metabolic parameters
研究概览
简要总结
The aim of this study is observation, in an Italian real-world setting, of metabolic effects in patients with schizophrenia who will switch from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or to one of the other four most used atypical antipsychotics.
详细描述
The aim of this study is the observation, in psychiatric Italian real-world settings, of metabolic effects, effectiveness, side effects and therapeutic adherence in patients with schizophrenia who switched, for any reason (efficacy, safety, metabolic problems, therapeutic adherence or patient's request), from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or with one of the four most used atypical antipsychotics in Italy (aripiprazole, olanzapine, quetiapine, risperidone). Patient's past medical and psychiatric history of the last 12 months will be also evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with a diagnosis of schizophrenia according to DSM-
- •Patients who gave their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
- •Male and female patients ≥ of 18 years old at baseline.
- •Patients treated or in treatment with any typical or atypical antipsychotic monotherapy or polytherapy.
- •Patients switched from the pre-existing therapy to lurasidone, aripiprazole, olanzapine, quetiapine or risperidone in monotherapy within the preceding 2 weeks. The date of the switch is considered as baseline.
排除标准
- •Female patients who are pregnant or lactating
- •Patients fulfilling DSM-5 criteria for diagnosis of bipolar disorder and/or dementia.
- •Amphetamines and/or Opiates abuse or dependence , as defined by DSM-5 criteria.
- •Patients with no history of antipsychotics use.
- •Patients recruited in another study as follows:
- •currently enrolled in any pharmacological or non-pharmacological, interventional or observational study:
- •who participated in the last 30 days to any observational or no-profit interventional study;
- •who participated in the last 12 months to any interventional commercially sponsored study.
研究组 & 干预措施
COHORT A: Lurasidone
Patients treated with Lurasidone
干预措施: Lurasidone (Drug)
COHORT B: aripiprazole, olanzapine, quetiapine or risperidone)
Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone)
干预措施: aripiprazole, olanzapine, quetiapine or risperidone (Drug)
结局指标
主要结局
Change in the metabolic parameters
时间窗: 4 weeks
Change in metabolic syndrome in 3 of 5 parameters: 1. Arterial hypertension defined as. systolic pressure ≥ 130 mmHg and/or diastolic pressure ≥85 mmHg or treatment for hypertension. 2. Waist Circumference ≥ 90 cm in men or ≥ 80 cm in women. 3. Fasting Plasma Glucose ≥5.6 mmol/l and/or known treatment for hyperglycemia. 4. Triglycerides ≥1.7 mmol/l or medication for elevated triglycerides. 5. HDL Cholesterol ≤ 1.0 mmol/l in men and ≤1.3 mmol/l for women or taking medication.
次要结局
- Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months(12 months before baseline (switch to any atypical antipsychotics))