Status:

COMPLETED

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

Lead Sponsor:

Aziende Chimiche Riunite Angelini Francesco S.p.A

Conditions:

Schizophrenia

Eligibility:

All Genders

18+ years

Brief Summary

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 ...

Detailed 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 swi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 13 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 31 2022

Estimated Enrollment :

95 Patients enrolled

Trial Details

Trial ID

NCT04312503

Start Date

July 13 2020

End Date

October 31 2022

Last Update

May 6 2023

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Ospedali Riuniti SOD di Clinica Psichiatrica

Ancona, AN, Italy, 60126

2

Spedali Civili di Brescia Dipartimento di Salute Mentale 1

Brescia, BS, Italy, 25123

3

A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)

Cagliari, CA, Italy, 09124

4

P.O. Gaspare Rodolico - U.O.C. di Psichiatria

Catania, CT, Italy, 95125