Schizophrenia Clinical Trial
— SWITCHOfficial title:
Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia"
Verified date | May 2023 |
Source | Aziende Chimiche Riunite Angelini Francesco S.p.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedali Riuniti SOD di Clinica Psichiatrica | Ancona | AN |
Italy | Spedali Civili di Brescia Dipartimento di Salute Mentale 1 | Brescia | BS |
Italy | A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA) | Cagliari | CA |
Italy | P.O. Gaspare Rodolico - U.O.C. di Psichiatria | Catania | CT |
Italy | AO Mater Domini U.O. Psichiatria | Catanzaro | CZ |
Italy | A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO) | Foggia | FG |
Italy | IRCCS Ospedale Policlinico San Martino | Genova | GE |
Italy | Clinica Von Sibenthal Via della Madonnina, 1 | Genzano Di Roma | RM |
Italy | DSM Dipartimento Salute Mentale | Lecce | LE |
Italy | Ospedale Luigi Sacco, S.C. Psichiatria 2 | Milan | MI |
Italy | Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria | Milan | MI |
Italy | Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione | Milan | MI |
Italy | Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale | Monza | MB |
Italy | Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria | Napoli | |
Italy | A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10 | Orbassano | TO |
Italy | III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD) | Padova | PD |
Italy | Azienda Ospedaliero Universitaria Sant'Andrea | Roma | RM |
Italy | Azienda Ospedaliera - Universitaria Senese | Siena |
Lead Sponsor | Collaborator |
---|---|
Aziende Chimiche Riunite Angelini Francesco S.p.A |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
4 weeks | |
Secondary | 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. |
12 months before baseline (switch to any atypical antipsychotics) |
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