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

Schizophrenia Clinical Trial

— SWITCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312503
• Other study ID #: 151(A)PO18531
• Status: Completed
• Start date: July 13, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone
Patients are treated with dosages according clinical practice
• aripiprazole, olanzapine, quetiapine or risperidone
Patients are treated with dosages according clinical practice

Locations

Country	Name	City	State
Italy	Ospedali Riuniti SOD di Clinica Psichiatrica	Ancona	AN
Italy	Spedali Civili di Brescia Dipartimento di Salute Mentale 1	Brescia	BS
Italy	A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)	Cagliari	CA
Italy	P.O. Gaspare Rodolico - U.O.C. di Psichiatria	Catania	CT
Italy	AO Mater Domini U.O. Psichiatria	Catanzaro	CZ
Italy	A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)	Foggia	FG
Italy	IRCCS Ospedale Policlinico San Martino	Genova	GE
Italy	Clinica Von Sibenthal Via della Madonnina, 1	Genzano Di Roma	RM
Italy	DSM Dipartimento Salute Mentale	Lecce	LE
Italy	Ospedale Luigi Sacco, S.C. Psichiatria 2	Milan	MI
Italy	Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria	Milan	MI
Italy	Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione	Milan	MI
Italy	Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale	Monza	MB
Italy	Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria	Napoli
Italy	A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10	Orbassano	TO
Italy	III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)	Padova	PD
Italy	Azienda Ospedaliero Universitaria Sant'Andrea	Roma	RM
Italy	Azienda Ospedaliera - Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)