Status:
TERMINATED
A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
Lead Sponsor:
Angelini Farmacéutica
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Brief Summary
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 serv...
Detailed Description
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 (psy...
Eligibility Criteria
Inclusion
- Female and male patients ≥ 18 years of age.
- Patients with schizophrenia based on the Diagnostic of Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- 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:
- Cohort A: patients who are prescribed to switch to lurasidone (lurasidone cohort)
- Cohort B: patients who are prescribed to switch to any other monotherapy SGA (other SGA cohort) \*Treatment switch and overlap period will be performed according to clinical practice and medical criteria.
- Written informed consent prior to participation.
Exclusion
- Patients with a known cardiovascular disease or suspected of having a heart disease.
- Pregnant or breastfeeding women.
- Patients diagnosed with at least one of the following: depression with psychotic symptoms, schizoaffective disorder, bipolar disorder or organic brain syndromes; Patients with active suicidal ideation or patients who have habitual and sustained consumption of alcohol and / or other toxic substances are also excluded.
- Patients who had been treated with a long-acting within the last 6 months, or within last year in case of Trevicta®.
- Concomitant treatments with antipsychotics for insomnia or anxiety (i.e., low doses of quetiapine, etumine, levomepromazine or similar). Concomitant treatment with sedative substances not considered antipsychotics (i.e., benzodiazepines or similar) when they are being taking regularly and at unchanged low doses are allowed.
- Patients with history of seizures, stroke, neuroleptic malignant syndrome or epilepsy are excluded.
- Current participation in any clinical trial.
- Patients for whom further follow-up is not possible at the enrolling site.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04742413
Start Date
December 29 2020
End Date
March 15 2022
Last Update
September 22 2022
Active Locations (10)
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1
Hospital Regional de Málaga
Málaga, Andalusia, Spain
2
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
3
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
4
Complejo Asistencial Universitario de León
León, Castille and León, Spain