A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 10
- 主要终点
- To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
研究概览
简要总结
A 12-Month Observational Prospective Multicentre Cohort Study based on existing and newly collected data of schizophrenia patients followed-up for one year in secondary care settings (psychiatric services). Schizophrenia patients will be enrolled in a consecutive manner over a period of 6 month into two cohorts according to their prescribing switching treatment: to lurasidone (cohort A) and to another SGA (cohort B).
详细描述
Study design A 12-Month observational prospective multicentre cohort study based on existing and newly collected data of schizophrenia patients followed-up for one year in secondary care settings (psychiatric services).
Patients will be selected by the specialist when required to switch the SGA therapy for schizophrenia (index data). Schizophrenia patients will be enrolled in a consecutive manner over a period of 6 month into two cohorts:
- Cohort A: patients who are prescribed to switch to lurasidone (lurasidone cohort)
- Cohort B: patients who are prescribed to switch to any other monotherapy SGA (other SGA cohort) The decision to switch the SGA treatment and prescribe the new treatment is done previously and independent from the decision to enter the patient into the study.
Visit 0 will be performed when the investigator consider necessary to perform the treatment switch and patients give their informed consent to participate in the study. All patients will sign the Informed consent before starting the data collection.
The duration of the study will be 12 months of follow-up after switching (visit 0): month 1 (visit 1), month 3 (visit 2), month 6 (visit 3) and month 12 (visit 4). Moreover, the clinical data of the patients recorded previous the index data will be collected in order to ensure that these patients were on an SGA monotherapy for a minimum of 3 months before switching to maximize potential weight gain and dysmetabolic problems that occurs early during the treatment. Preferably, patients have to be on treatment for a year or more before switching so that they have reached a weight plateau.
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
- •Female and male patients ≥ 18 years of age.
- •Patients with schizophrenia based on the Diagnostic of Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •Patients currently treated with oral SGA monotherapy for a minimum of 3 months that are prescribed* to switch to another oral SGA medication. Patients will be included in a cohort depending on the switching treatment prescribed:
- •Cohort A: patients who are prescribed to switch to lurasidone (lurasidone cohort)
- •Cohort B: patients who are prescribed to switch to any other monotherapy SGA (other SGA cohort) *Treatment switch and overlap period will be performed according to clinical practice and medical criteria.
- •Written informed consent prior to participation.
排除标准
- •Patients with a known cardiovascular disease or suspected of having a heart disease.
- •Pregnant or breastfeeding women.
- •Patients diagnosed with at least one of the following: depression with psychotic symptoms, schizoaffective disorder, bipolar disorder or organic brain syndromes; Patients with active suicidal ideation or patients who have habitual and sustained consumption of alcohol and / or other toxic substances are also excluded.
- •Patients who had been treated with a long-acting within the last 6 months, or within last year in case of Trevicta®.
- •Concomitant treatments with antipsychotics for insomnia or anxiety (i.e., low doses of quetiapine, etumine, levomepromazine or similar). Concomitant treatment with sedative substances not considered antipsychotics (i.e., benzodiazepines or similar) when they are being taking regularly and at unchanged low doses are allowed.
- •Patients with history of seizures, stroke, neuroleptic malignant syndrome or epilepsy are excluded.
- •Current participation in any clinical trial.
- •Patients for whom further follow-up is not possible at the enrolling site.
结局指标
主要结局
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
时间窗: Month 3
fasting glucose levels (mg/dL)
次要结局
- Health resources use(Month 3, month 6 and month 12)
- Analyze cardiometabolic profile changes based on metabolic syndrome factors(Month 3, month 6 and month 12)
- To evaluate effectiveness from baseline.(Month 3, month 6 and month 12)
- Health-related quality of life (HRQoL) changes based on patient reported outcomes(Month 3, month 6 and month 12)
- Evaluate safety and tolerability(through study completion, an average of 1 year)
- Analyze cardiometabolic profile based on other cardiovascular risk factors(Month 1, month 3, month 6 and month 12)
- QTc levels(Month 12)
- Reason for SGA discontinuation(through study completion, an average of 1 year)
- Change in weight(Month 1, month 3, month 6 and month 12)