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

May 5, 2023 updated by: Aziende Chimiche Riunite Angelini Francesco S.p.A

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria
      • Siena, Italy, 53100
        • Azienda Ospedaliera - Universitaria Senese
    • AN
      • Ancona, AN, Italy, 60126
        • Ospedali Riuniti SOD di Clinica Psichiatrica
    • BS
      • Brescia, BS, Italy, 25123
        • Spedali Civili di Brescia Dipartimento di Salute Mentale 1
    • CA
      • Cagliari, CA, Italy, 09124
        • A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)
    • CT
      • Catania, CT, Italy, 95125
        • P.O. Gaspare Rodolico - U.O.C. di Psichiatria
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • AO Mater Domini U.O. Psichiatria
    • FG
      • Foggia, FG, Italy, 71121
        • A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)
    • GE
      • Genova, GE, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
    • LE
      • Lecce, LE, Italy, 73100
        • DSM Dipartimento Salute Mentale
    • MB
      • Monza, MB, Italy, 209900
        • Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale
    • MI
      • Milan, MI, Italy, 20122
        • Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria
      • Milan, MI, Italy, 20127
        • Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione
      • Milan, MI, Italy, 20157
        • Ospedale Luigi Sacco, S.C. Psichiatria 2
    • PD
      • Padova, PD, Italy, 35128
        • III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)
    • RM
      • Genzano Di Roma, RM, Italy, 00045
        • Clinica Von Sibenthal Via della Madonnina, 1
      • Roma, RM, Italy, 00189
        • Azienda Ospedaliero Universitaria Sant'Andrea
    • TO
      • Orbassano, TO, Italy, 10043
        • A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COHORT A: Lurasidone
Patients treated with Lurasidone
Drug: Lurasidone
Patients are treated with dosages according clinical practice
Other Names:
  • Latuda
COHORT B: aripiprazole, olanzapine, quetiapine or risperidone)
Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone)
Drug: aripiprazole, olanzapine, quetiapine or risperidone
Patients are treated with dosages according clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the metabolic parameters
Time Frame: 4 weeks

Change in metabolic syndrome in 3 of 5 parameters:

  1. Arterial hypertension defined as. systolic pressure ≥ 130 mmHg and/or diastolic pressure ≥85 mmHg or treatment for hypertension.
  2. Waist Circumference ≥ 90 cm in men or ≥ 80 cm in women.
  3. Fasting Plasma Glucose ≥5.6 mmol/l and/or known treatment for hyperglycemia.
  4. Triglycerides ≥1.7 mmol/l or medication for elevated triglycerides.
  5. HDL Cholesterol ≤ 1.0 mmol/l in men and ≤1.3 mmol/l for women or taking medication.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months
Time Frame: 12 months before baseline (switch to any atypical antipsychotics)

Change in metabolic syndrome in 3 of 5 parameters:

  1. Arterial hypertension defined as. systolic pressure ≥ 130 mmHg and/or diastolic pressure ≥85 mmHg or treatment for hypertension.
  2. Waist Circumference ≥ 90 cm in men or ≥ 80 cm in women.
  3. Fasting Plasma Glucose ≥5.6 mmol/l and/or known treatment for hyperglycemia.
  4. Triglycerides ≥1.7 mmol/l or medication for elevated triglycerides.
  5. 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151(A)PO18531

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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