An observational study in Schizophrenia, sponsored by Angelini Farmacéutica. Terminated at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by Angelini Farmacéutica (part of Angelini Pharma) · Observational
A 12-Month Observational Prospective Multicentre Cohort Study based on existing and newly collected data of schizophrenia patients followed-up for one year in secondary care settings (psychiatric services). Schizophrenia patients will be enrolled in a consecutive manner over a period of 6 month into two cohorts according to their prescribing switching treatment: to lurasidone (cohort A) and to another SGA (cohort B).
Study design A 12-Month observational prospective multicentre cohort study based on existing and newly collected data of schizophrenia patients followed-up for one year in secondary care settings (psychiatric services).
Patients will be selected by the specialist when required to switch the SGA therapy for schizophrenia (index data). Schizophrenia patients will be enrolled in a consecutive manner over a period of 6 month into two cohorts:
Visit 0 will be performed when the investigator consider necessary to perform the treatment switch and patients give their informed consent to participate in the study. All patients will sign the Informed consent before starting the data collection.
The duration of the study will be 12 months of follow-up after switching (visit 0): month 1 (visit 1), month 3 (visit 2), month 6 (visit 3) and month 12 (visit 4). Moreover, the clinical data of the patients recorded previous the index data will be collected in order to ensure that these patients were on an SGA monotherapy for a minimum of 3 months before switching to maximize potential weight gain and dysmetabolic problems that occurs early during the treatment. Preferably, patients have to be on treatment for a year or more before switching so that they have reached a weight plateau.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 9 is below the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients ≥ 18 years old, with schizophrenia based on the DSM-5, treated with oral SGA monotherapy for a minimum of 3 months before switching to lurasidone or another SGA, will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients currently treated with oral SGA monotherapy for a minimum of 3 months that are prescribed* to switch to another oral SGA medication. Patients will be included in a cohort depending on the switching treatment prescribed:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are prescribed to switch to lurasidone (lurasidone cohort)
Patients who are prescribed to switch to any other monotherapy SGA (other SGA cohort)
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Body mass index, BMI (kg/m\^2)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Abdominal perimeter (cm)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Triglycerides(mg/dL)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
High density lipoproteins-cholesterol (mg/dL)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
systolic blood pressure (mm Hg)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Diastolic blood pressure (mm Hg)
Time frame: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
fasting glucose levels (mg/dL)
Time frame: Month 3
To evaluate effectiveness from baseline.
To evaluate effectiveness based on Brief Psychiatric Rating Scale scores from baseline. Smaller scores mean a better outcome. Min: 24; Max:168
Time frame: Month 3, month 6 and month 12
To evaluate effectiveness from baseline.
To evaluate effectiveness based on Clinical Global Impressions Ratings scores from baseline. Smaller scores mean a better outcome
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Body Mass Indez (kg/m\^2) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
abdominal perimeter (cm) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Triglycerides (mg/dL) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
High Densitity Lipoproteins - cholesterol (mg/dL) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Systolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Diastolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
fasting glucose levels (mg/dL) changes from baseline to visit 1, 3 and 4.
Time frame: Month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
To analyze cardiometabolic profile based on other cardiovascular risk factors (LDL-c (mg/dL), TC (mg/dL), HbA1c (%), creatinine (mg/dL), eGFR and prolactin (ng/ml) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Low Density Lipoproteins - cholesterol (mg/dL) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Total Cholesterol (mg/dL) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Hemoglobin A1c protein (%) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
creatinine (mg/dL) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
prolactine (ng/mL) changes from baseline
Time frame: Month 1, month 3, month 6 and month 12
QTc levels
To compare QTc levels from baseline to visit 4 (month 12)
Time frame: Month 12
Change in weight
To analyze the percentage of change in weight (kg) from baseline.
Time frame: Month 1, month 3, month 6 and month 12
Health-related quality of life (HRQoL) changes based on patient reported outcomes
To describe the health-related quality of life (HRQoL) changes based on patient reported outcomes from baseline.
Time frame: Month 3, month 6 and month 12
Health resources use
To analyze the health resources use during the study.
Time frame: Month 3, month 6 and month 12
Evaluate safety and tolerability
To evaluate safety and tolerability based on adverse events / adverse drug reactions (serious and non-serious) reported along the study
Time frame: through study completion, an average of 1 year
Reason for SGA discontinuation
To evaluate the reason for SGA discontinuation by antipsychotic therapy.
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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