Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone
* Drug: aripiprazole, olanzapine, quetiapine or risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of schizophrenia according to DSM-5. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COHORT A: Lurasidone<br>Patients treated with Lurasidone | Drug: Lurasidone<br>* Patients are treated with dosages according clinical practice<br>* Other names: Latuda;|
| COHORT B: aripiprazole, olanzapine, quetiapine or risperidone)<br>Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone) | Drug: aripiprazole, olanzapine, quetiapine or risperidone<br>* Patients are treated with dosages according clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the metabolic parameters | Change in metabolic syndrome in 3 of 5 parameters: Arterial hypertension defined as. systolic pressure ≥ 130 mmHg and/or diastolic pressure ≥85 mmHg or treatment for hypertension. Waist Circumference ≥ 90 cm in men or ≥ 80 cm in women. Fasting Plasma Glucose ≥5.6 mmol/l and/or known treatment for hyperglycemia. Triglycerides ≥1.7 mmol/l or medication for elevated triglycerides. HDL Cholesterol ≤ 1.0 mmol/l in men and ≤1.3 mmol/l for women or taking medication. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months | Change in metabolic syndrome in 3 of 5 parameters: Arterial hypertension defined as. systolic pressure ≥ 130 mmHg and/or diastolic pressure ≥85 mmHg or treatment for hypertension. Waist Circumference ≥ 90 cm in men or ≥ 80 cm in women. Fasting Plasma Glucose ≥5.6 mmol/l and/or known treatment for hyperglycemia. Triglycerides ≥1.7 mmol/l or medication for elevated triglycerides. HDL Cholesterol ≤ 1.0 mmol/l in men and ≤1.3 mmol/l for women or taking medication. | 12 months before baseline (switch to any atypical antipsychotics) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, lurasidone, antipsychotics, metabolic syndrome, switch