- ICH GCP
- US Clinical Trials Registry
- 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. (RESPECT)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- Hospital 12 de Octubre
-
Madrid, Spain
- Hospital Universitario La Paz
-
-
Andalucia
-
Málaga, Andalucia, Spain
- Hospital Regional De Malaga
-
-
Baleares
-
Palma De Mallorca, Baleares, Spain
- Hospital Son Llatzer
-
Palma de Mallorca, Baleares, Spain
- Hospital Universitario Son Espases
-
-
Castilla Leon
-
Zamora, Castilla Leon, Spain
- Complejo Asistencial de Zamora
-
-
Castilla León
-
León, Castilla León, Spain
- Complejo Asistencial Universitario de León
-
Salamanca, Castilla León, Spain
- H. U. Salamanca
-
-
Galicia
-
Santiago De Compostela, Galicia, Spain
- CHU Santiago
-
Vigo, Galicia, Spain
- Hospital Álvaro Cunqueiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
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.
Time Frame: Month 3
|
Abdominal perimeter (cm)
|
Month 3
|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
Triglycerides(mg/dL)
|
Month 3
|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
High density lipoproteins-cholesterol (mg/dL)
|
Month 3
|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
systolic blood pressure (mm Hg)
|
Month 3
|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
Diastolic blood pressure (mm Hg)
|
Month 3
|
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time Frame: Month 3
|
fasting glucose levels (mg/dL)
|
Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate effectiveness from baseline.
Time Frame: Month 3, month 6 and month 12
|
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
|
To evaluate effectiveness from baseline.
Time Frame: Month 3, month 6 and month 12
|
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
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
Body Mass Indez (kg/m^2) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
abdominal perimeter (cm) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
Triglycerides (mg/dL) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
High Densitity Lipoproteins - cholesterol (mg/dL) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
Systolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
Diastolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time Frame: Month 3, month 6 and month 12
|
fasting glucose levels (mg/dL) changes from baseline to visit 1, 3 and 4.
|
Month 3, month 6 and month 12
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
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
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
Low Density Lipoproteins - cholesterol (mg/dL) changes from baseline
|
Month 1, month 3, month 6 and month 12
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
Total Cholesterol (mg/dL) changes from baseline
|
Month 1, month 3, month 6 and month 12
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
Hemoglobin A1c protein (%) changes from baseline
|
Month 1, month 3, month 6 and month 12
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
creatinine (mg/dL) changes from baseline
|
Month 1, month 3, month 6 and month 12
|
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time Frame: Month 1, month 3, month 6 and month 12
|
prolactine (ng/mL) changes from baseline
|
Month 1, month 3, month 6 and month 12
|
QTc levels
Time Frame: Month 12
|
To compare QTc levels from baseline to visit 4 (month 12)
|
Month 12
|
Change in weight
Time Frame: Month 1, month 3, month 6 and month 12
|
To analyze the percentage of change in weight (kg) from baseline.
|
Month 1, month 3, month 6 and month 12
|
Health-related quality of life (HRQoL) changes based on patient reported outcomes
Time Frame: Month 3, month 6 and month 12
|
To describe the health-related quality of life (HRQoL) changes based on patient reported outcomes from baseline.
|
Month 3, month 6 and month 12
|
Health resources use
Time Frame: Month 3, month 6 and month 12
|
To analyze the health resources use during the study.
|
Month 3, month 6 and month 12
|
Evaluate safety and tolerability
Time Frame: through study completion, an average of 1 year
|
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
|
Reason for SGA discontinuation
Time Frame: through study completion, an average of 1 year
|
To evaluate the reason for SGA discontinuation by antipsychotic therapy.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANG-LUR-2020-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Rakitzi, StavroulaActive, not recruiting
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance