Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742413
Status:
TERMINATED
Last Update Posted:
2022-09-22
First Post:
2021-01-22
Brief Title:
A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia RESPECT Study
Sponsor:
Angelini Farmacéutica
Organization:
Angelini Farmacéutica
Study Overview
Official Title:
A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia RESPECT Study
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was not completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPECT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None