Clinical trial NCT04312503: Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"
Official title: Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: schizophrenia
lurasidone
antipsychotics
metabolic syndrome
switch
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients (aged \> 18 years) affected by schizophrenia according to DSM-5 (Appendix A).

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 to monotherapy with lurasidone or to one of the other four most used atypical antipsychotics.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the metabolic parameters
timeFrame: 4 weeks
Secondary outcomes:
measure: Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months
timeFrame: 12 months before baseline (switch to any atypical antipsychotics)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti SOD di Clinica Psichiatrica
state: AN
city: Brescia
country: Italy
facility: Spedali Civili di Brescia Dipartimento di Salute Mentale 1
state: BS
city: Cagliari
country: Italy
facility: A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)
state: CA
city: Catania
country: Italy
facility: P.O. Gaspare Rodolico - U.O.C. di Psichiatria
state: CT
city: Catanzaro
country: Italy
facility: AO Mater Domini U.O. Psichiatria
state: CZ
city: Foggia
country: Italy
facility: A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)
state: FG
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: GE
city: Lecce
country: Italy
facility: DSM Dipartimento Salute Mentale
state: LE
city: Monza
country: Italy
facility: Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale
state: MB
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria
state: MI
city: Milan
country: Italy
facility: Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione
state: MI
city: Milan
country: Italy
facility: Ospedale Luigi Sacco, S.C. Psichiatria 2
state: MI
city: Padova
country: Italy
facility: III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)
state: PD
city: Genzano Di Roma
country: Italy
facility: Clinica Von Sibenthal Via della Madonnina, 1
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Andrea
state: RM
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10
state: TO
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria
city: Siena
country: Italy
facility: Azienda Ospedaliera - Universitaria Senese
Study officials:
References: