Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia" (SWITCH)

Angelini Pharma

Status

Completed

Conditions

Schizophrenia

Treatments

Drug: Lurasidone

Drug: aripiprazole, olanzapine, quetiapine or risperidone

Study type

Observational

Funder types

Industry

Identifiers

NCT04312503

151(A)PO18531

Details and patient eligibility

About

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.

Full description

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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.