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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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