SchizophreniaSWITCHNCT04312503
Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"
An observational study of Schizophrenia, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 18 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone and aripiprazole, olanzapine, quetiapine or risperidone
- How many people
- 95 participants
- Where
- 18 sitesItaly
- Study dates
- 13 Jul 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients (aged > 18 years) affected by schizophrenia according to DSM-5 (Appendix A).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
Ospedali Riuniti SOD di Clinica Psichiatrica
Ancona, AN, 60126
Spedali Civili di Brescia Dipartimento di Salute Mentale 1
Brescia, BS, 25123
A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA)
Cagliari, CA, 09124
P.O. Gaspare Rodolico - U.O.C. di Psichiatria
Catania, CT, 95125
AO Mater Domini U.O. Psichiatria
Catanzaro, CZ, 88100
A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO)
Foggia, FG, 71121
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Clinica Von Sibenthal Via della Madonnina, 1
Genzano di Roma, RM, 00045
DSM Dipartimento Salute Mentale
Lecce, LE, 73100
Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria
Milan, MI, 20122
Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione
Milan, MI, 20127
Ospedale Luigi Sacco, S.C. Psichiatria 2
Milan, MI, 20157
Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale
Monza, MB, 209900
Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria
Naples, 80131
A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10
Orbassano, TO, 10043
III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD)
Padova, PD, 35128
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, RM, 00189
Azienda Ospedaliera - Universitaria Senese
Siena, 53100
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone, aripiprazole, olanzapine, quetiapine or risperidone
- Keywords
- schizophrenia, lurasidone, antipsychotics, metabolic syndrome, switch
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Also called Latuda
Patients are treated with dosages according clinical practice
aripiprazole, olanzapine, quetiapine or risperidoneDrug
Patients are treated with dosages according clinical practice
| Study group | Role | What they receive |
|---|---|---|
| COHORT A: Lurasidone | Patients treated with Lurasidone Receives: Drug: Lurasidone | |
| COHORT B: aripiprazole, olanzapine, quetiapine or risperidone) | Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone) Receives: Drug: aripiprazole, olanzapine, quetiapine or risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 12 months before baseline (switch to any atypical antipsychotics)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start13 Jul 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312503
- Sponsor's protocol ID
- 151(A)PO18531
- Acronym
- SWITCH
- Status last verified
- May 2023
- First submitted
- 16 Mar 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia"
- ClinicalTrials.gov ID
- NCT04312503
- Acronym / sponsor ID
- SWITCH / 151(A)PO18531
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, lurasidone, antipsychotics, metabolic syndrome, switch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COHORT A: Lurasidone | – | Drug: LurasidonePatients treated with Lurasidone |
| COHORT B: aripiprazole, olanzapine, quetiapine or risperidone) | – | Drug: aripiprazole, olanzapine, quetiapine or risperidonePatients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients (aged > 18 years) affected by schizophrenia according to DSM-5 (Appendix A).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneAlso: LatudaPatients are treated with dosages according clinical practice | Drug | COHORT A: Lurasidone |
| aripiprazole, olanzapine, quetiapine or risperidonePatients are treated with dosages according clinical practice | Drug | COHORT B: aripiprazole, olanzapine, quetiapine or risperidone) |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 18 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the metabolic parameters (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.