Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"
SWITCH
1 other identifier
observational
95
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedMay 6, 2023
May 1, 2023
2.3 years
March 16, 2020
May 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the metabolic parameters
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 Outcomes (1)
Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months
12 months before baseline (switch to any atypical antipsychotics)
Study Arms (2)
COHORT A: Lurasidone
Patients treated with Lurasidone
COHORT B: aripiprazole, olanzapine, quetiapine or risperidone)
Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone)
Interventions
Patients are treated with dosages according clinical practice
Patients are treated with dosages according clinical practice
Eligibility Criteria
The study population will include adult patients (aged \> 18 years) affected by schizophrenia according to DSM-5 (Appendix A).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Ospedali Riuniti SOD di Clinica Psichiatrica
Ancona, AN, 60126, Italy
Spedali Civili di Brescia Dipartimento di Salute Mentale 1
Brescia, BS, 25123, Italy
A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)
Cagliari, CA, 09124, Italy
P.O. Gaspare Rodolico - U.O.C. di Psichiatria
Catania, CT, 95125, Italy
AO Mater Domini U.O. Psichiatria
Catanzaro, CZ, 88100, Italy
A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)
Foggia, FG, 71121, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132, Italy
DSM Dipartimento Salute Mentale
Lecce, LE, 73100, Italy
Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale
Monza, MB, 209900, Italy
Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria
Milan, MI, 20122, Italy
Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione
Milan, MI, 20127, Italy
Ospedale Luigi Sacco, S.C. Psichiatria 2
Milan, MI, 20157, Italy
III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)
Padua, PD, 35128, Italy
Clinica Von Sibenthal Via della Madonnina, 1
Genzano di Roma, RM, 00045, Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, RM, 00189, Italy
A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10
Orbassano, TO, 10043, Italy
Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria
Napoli, 80131, Italy
Azienda Ospedaliera - Universitaria Senese
Siena, 53100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2020
First Posted
March 18, 2020
Study Start
July 13, 2020
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
May 6, 2023
Record last verified: 2023-05