Clinical trial NCT04742413: A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
Official title: A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Lead sponsor: Angelini Farmacéutica
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
measure: To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
timeFrame: Month 3
Secondary outcomes:
measure: To evaluate effectiveness from baseline.
timeFrame: Month 3, month 6 and month 12
measure: To evaluate effectiveness from baseline.
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile changes based on metabolic syndrome factors
timeFrame: Month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: Analyze cardiometabolic profile based on other cardiovascular risk factors
timeFrame: Month 1, month 3, month 6 and month 12
measure: QTc levels
timeFrame: Month 12
measure: Change in weight
timeFrame: Month 1, month 3, month 6 and month 12
measure: Health-related quality of life (HRQoL) changes based on patient reported outcomes
timeFrame: Month 3, month 6 and month 12
measure: Health resources use
timeFrame: Month 3, month 6 and month 12
measure: Evaluate safety and tolerability
timeFrame: through study completion, an average of 1 year
measure: Reason for SGA discontinuation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
state: Andalucia
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora
state: Castilla Leon
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
state: Castilla León
city: Salamanca
country: Spain
facility: H. U. Salamanca
state: Castilla León
city: Santiago De Compostela
country: Spain
facility: CHU Santiago
state: Galicia
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Galicia
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
Study officials:
References: