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

NCT ID: NCT04312503

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-13

Study Completion Date

2022-10-31

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.

Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COHORT A: Lurasidone

Patients treated with Lurasidone

Lurasidone

Intervention Type DRUG

Patients are treated with dosages according clinical practice

COHORT B: aripiprazole, olanzapine, quetiapine or risperidone)

Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone)

aripiprazole, olanzapine, quetiapine or risperidone

Intervention Type DRUG

Patients are treated with dosages according clinical practice

Interventions

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Lurasidone

Patients are treated with dosages according clinical practice

Intervention Type DRUG

aripiprazole, olanzapine, quetiapine or risperidone

Patients are treated with dosages according clinical practice

Intervention Type DRUG

Other Intervention Names

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Latuda

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedali Riuniti SOD di Clinica Psichiatrica

Ancona, AN, Italy

Site Status

Spedali Civili di Brescia Dipartimento di Salute Mentale 1

Brescia, BS, Italy

Site Status

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

Cagliari, CA, Italy

Site Status

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

Catania, CT, Italy

Site Status

AO Mater Domini U.O. Psichiatria

Catanzaro, CZ, Italy

Site Status

A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)

Foggia, FG, Italy

Site Status

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status

DSM Dipartimento Salute Mentale

Lecce, LE, Italy

Site Status

Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale

Monza, MB, Italy

Site Status

Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria

Milan, MI, Italy

Site Status

Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione

Milan, MI, Italy

Site Status

Ospedale Luigi Sacco, S.C. Psichiatria 2

Milan, MI, Italy

Site Status

III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)

Padua, PD, Italy

Site Status

Clinica Von Sibenthal Via della Madonnina, 1

Genzano di Roma, RM, Italy

Site Status

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, RM, Italy

Site Status

A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10

Orbassano, TO, Italy

Site Status

Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria

Napoli, , Italy

Site Status

Azienda Ospedaliera - Universitaria Senese

Siena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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151(A)PO18531

Identifier Type: -

Identifier Source: org_study_id

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