A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.

NCT04742413 | Terminated

• 1 other identifier: ANG-LUR-2020-01
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 10

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 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).

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (7)

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  Body mass index, BMI (kg/m\^2)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  Abdominal perimeter (cm)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  Triglycerides(mg/dL)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  High density lipoproteins-cholesterol (mg/dL)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  systolic blood pressure (mm Hg)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  Diastolic blood pressure (mm Hg)

  Month 3

• To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.

  fasting glucose levels (mg/dL)

  Month 3

Secondary Outcomes (21)

• To evaluate effectiveness from baseline.

  Month 3, month 6 and month 12

• To evaluate effectiveness from baseline.

  Month 3, month 6 and month 12

• Analyze cardiometabolic profile changes based on metabolic syndrome factors

  Month 3, month 6 and month 12

• Analyze cardiometabolic profile changes based on metabolic syndrome factors

  Month 3, month 6 and month 12

• Analyze cardiometabolic profile changes based on metabolic syndrome factors

  Month 3, month 6 and month 12

Study Arms (2)

A

Patients who are prescribed to switch to lurasidone (lurasidone cohort)

B

Patients who are prescribed to switch to any other monotherapy SGA (other SGA cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angelini Farmacéutica: lead

Study Sites (10)

Hospital Regional de Málaga

Málaga, Andalusia, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Location

Complejo Asistencial Universitario de León

León, Castille and León, Spain

Location

H. U. Salamanca

Salamanca, Castille and León, Spain

Location

Complejo Asistencial de Zamora

Zamora, Castille and León, Spain

Location

CHU Santiago

Santiago de Compostela, Galicia, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Universitario la Paz

Madrid, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 8, 2021
• Study Start: December 29, 2020
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)