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

NCT ID: NCT04742413

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2022-03-15

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).

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 (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:

• 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) The decision to switch the SGA treatment and prescribe the new treatment is done previously and independent from the decision to enter the patient into the study.

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.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

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

No interventions assigned to this group

B

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Female and male patients ≥ 18 years of age.

2. Patients with schizophrenia based on the Diagnostic of Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

3. 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.

4. Written informed consent prior to participation.

Exclusion Criteria

1. Patients with a known cardiovascular disease or suspected of having a heart disease.

2. Pregnant or breastfeeding women.

3. 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.

4. Patients who had been treated with a long-acting within the last 6 months, or within last year in case of Trevicta®.

5. 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.

6. Patients with history of seizures, stroke, neuroleptic malignant syndrome or epilepsy are excluded.

7. Current participation in any clinical trial.

8. Patients for whom further follow-up is not possible at the enrolling site.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angelini Farmacéutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Regional de Málaga

Málaga, Andalusia, Spain

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Complejo Asistencial Universitario de León

León, Castille and León, Spain

H. U. Salamanca

Salamanca, Castille and León, Spain

Complejo Asistencial de Zamora

Zamora, Castille and León, Spain

CHU Santiago

Santiago de Compostela, Galicia, Spain

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Universitario la Paz

Madrid, , Spain

Countries

Spain

Other Identifiers

ANG-LUR-2020-01

Identifier Type: -

Identifier Source: org_study_id