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

Schizophrenia Clinical Trial

— RESPECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04742413
• Other study ID #: ANG-LUR-2020-01
• Status: Terminated
• Start date: December 29, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2022
• Source: Angelini Farmacéutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de León	León	Castilla León
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario la Paz	Madrid
Spain	Hospital Regional de Málaga	Málaga	Andalucia
Spain	Hospital Son Llatzer	Palma De Mallorca	Baleares
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Baleares
Spain	H. U. Salamanca	Salamanca	Castilla León
Spain	CHU Santiago	Santiago De Compostela	Galicia
Spain	Hospital Álvaro Cunqueiro	Vigo	Galicia
Spain	Complejo Asistencial de Zamora	Zamora	Castilla Leon

Sponsors (1)

Lead Sponsor	Collaborator
Angelini Farmacéutica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	Abdominal perimeter (cm)	Month 3
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	Triglycerides(mg/dL)	Month 3
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	High density lipoproteins-cholesterol (mg/dL)	Month 3
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	systolic blood pressure (mm Hg)	Month 3
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	Diastolic blood pressure (mm Hg)	Month 3
Primary	To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.	fasting glucose levels (mg/dL)	Month 3
Secondary	To evaluate effectiveness from baseline.	To evaluate effectiveness based on Brief Psychiatric Rating Scale scores from baseline. Smaller scores mean a better outcome. Min: 24; Max:168	Month 3, month 6 and month 12
Secondary	To evaluate effectiveness from baseline.	To evaluate effectiveness based on Clinical Global Impressions Ratings scores from baseline. Smaller scores mean a better outcome	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	Body Mass Indez (kg/m^2) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	abdominal perimeter (cm) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	Triglycerides (mg/dL) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	High Densitity Lipoproteins - cholesterol (mg/dL) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	Systolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	Diastolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile changes based on metabolic syndrome factors	fasting glucose levels (mg/dL) changes from baseline to visit 1, 3 and 4.	Month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	To analyze cardiometabolic profile based on other cardiovascular risk factors (LDL-c (mg/dL), TC (mg/dL), HbA1c (%), creatinine (mg/dL), eGFR and prolactin (ng/ml) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	Low Density Lipoproteins - cholesterol (mg/dL) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	Total Cholesterol (mg/dL) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	Hemoglobin A1c protein (%) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	creatinine (mg/dL) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	Analyze cardiometabolic profile based on other cardiovascular risk factors	prolactine (ng/mL) changes from baseline	Month 1, month 3, month 6 and month 12
Secondary	QTc levels	To compare QTc levels from baseline to visit 4 (month 12)	Month 12
Secondary	Change in weight	To analyze the percentage of change in weight (kg) from baseline.	Month 1, month 3, month 6 and month 12
Secondary	Health-related quality of life (HRQoL) changes based on patient reported outcomes	To describe the health-related quality of life (HRQoL) changes based on patient reported outcomes from baseline.	Month 3, month 6 and month 12
Secondary	Health resources use	To analyze the health resources use during the study.	Month 3, month 6 and month 12
Secondary	Evaluate safety and tolerability	To evaluate safety and tolerability based on adverse events / adverse drug reactions (serious and non-serious) reported along the study	through study completion, an average of 1 year
Secondary	Reason for SGA discontinuation	To evaluate the reason for SGA discontinuation by antipsychotic therapy.	through study completion, an average of 1 year