Private international group conducts Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia

Angelini Farmacéutica is enrolling patients into the clinical trial investigating A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study

This is 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 and to another SGA.

The study start date is December 29, 2020.

The trial is designed to enroll male and female 18 years and older and is being conducted in the Hospital Regional de Málaga, Málaga, Andalucia; Hospital Son Llatzer, Palma De Mallorca, Baleares; Hospital Universitario Son Espases, Palma de Mallorca, Baleares; Complejo Asistencial de Zamora, Zamora, Castilla Leon; Complejo Asistencial Universitario de León, León, Castilla León, Spain; H. U. Salamanca, Salamanca, Castilla León; CHU Santiago, Santiago De Compostela, Galicia; Hospital Álvaro Cunqueiro, Vigo, Galicia; Hospital 12 de Octubre, Madrid and Hospital Universitario la Paz, Madrid, Spain.

The patients that can be enrolled into this study include:

• 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.

There are a number of conditions that do not allow participation, such as:

• 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.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04742413