Skip to main content
OpenTrials
Completed

NCT Number: NCT04312503

Observational Study on the Effect of Switch to Lurasidone 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali Riuniti SOD di Clinica Psichiatrica, Ancona, AN, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lurasidone

Drug

Patients are treated with dosages according clinical practice

Other names: Latuda

aripiprazole, olanzapine, quetiapine or risperidone

Drug

Patients are treated with dosages according clinical practice

Primary outcomes

  1. Change in the metabolic parameters

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Industry

Registry information

Official study title

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

Acronym: SWITCH

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2020
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.