SchizophreniaRESPECTNCT04742413
A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
An observational study of Schizophrenia, run by Angelini Farmacéutica at 10 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 9 participants
- Where
- 10 sitesSpain
- Study dates
- 29 Dec 2020to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Complejo Asistencial Universitario de León
León, Castille and León
Hospital 12 de Octubre
Madrid
Hospital Universitario la Paz
Madrid
Hospital Regional de Málaga
Málaga, Andalusia
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands
H. U. Salamanca
Salamanca, Castille and León
CHU Santiago
Santiago de Compostela, Galicia
Hospital Álvaro Cunqueiro
Vigo, Galicia
Complejo Asistencial de Zamora
Zamora, Castille and León
About this study
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).
Read the 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
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Body mass index, BMI (kg/m^2)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Abdominal perimeter (cm)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Triglycerides(mg/dL)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
High density lipoproteins-cholesterol (mg/dL)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
systolic blood pressure (mm Hg)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Diastolic blood pressure (mm Hg)
Measured: Month 3
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
fasting glucose levels (mg/dL)
Measured: Month 3
Secondary outcomes (21)
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
Measured: Month 3, month 6 and month 12
To evaluate effectiveness from baseline.
To evaluate effectiveness based on Clinical Global Impressions Ratings scores from baseline. Smaller scores mean a better outcome
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Body Mass Indez (kg/m^2) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
abdominal perimeter (cm) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Triglycerides (mg/dL) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
High Densitity Lipoproteins - cholesterol (mg/dL) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Systolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Diastolic Blood Preassure (mm Hg) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
Analyze cardiometabolic profile changes based on metabolic syndrome factors
fasting glucose levels (mg/dL) changes from baseline to visit 1, 3 and 4.
Measured: Month 3, month 6 and month 12
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
Measured: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Low Density Lipoproteins - cholesterol (mg/dL) changes from baseline
Measured: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Total Cholesterol (mg/dL) changes from baseline
Measured: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
Hemoglobin A1c protein (%) changes from baseline
Measured: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
creatinine (mg/dL) changes from baseline
Measured: Month 1, month 3, month 6 and month 12
Analyze cardiometabolic profile based on other cardiovascular risk factors
prolactine (ng/mL) changes from baseline
Measured: Month 1, month 3, month 6 and month 12
QTc levels
To compare QTc levels from baseline to visit 4 (month 12)
Measured: Month 12
Change in weight
To analyze the percentage of change in weight (kg) from baseline.
Measured: Month 1, month 3, month 6 and month 12
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.
Measured: Month 3, month 6 and month 12
Health resources use
To analyze the health resources use during the study.
Measured: Month 3, month 6 and month 12
Evaluate safety and tolerability
To evaluate safety and tolerability based on adverse events / adverse drug reactions (serious and non-serious) reported along the study
Measured: through study completion, an average of 1 year
Reason for SGA discontinuation
To evaluate the reason for SGA discontinuation by antipsychotic therapy.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start29 Dec 2020
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Why it stopped: Recruitment was not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelini Farmacéutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742413
- Sponsor's protocol ID
- ANG-LUR-2020-01
- Acronym
- RESPECT
- Status last verified
- Sep 2022
- First submitted
- 22 Jan 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month Observational Prospective Cohort Study to Analyze Cardiometabolic Profile Changes to Switch to Lurasidone in Patients With Schizophrenia. RESPECT Study.
- ClinicalTrials.gov ID
- NCT04742413
- Acronym / sponsor ID
- RESPECT / ANG-LUR-2020-01
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment was not completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Angelini FarmacéuticaIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- Written informed consent prior to participation.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time frame: Month 3
Abdominal perimeter (cm)
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2.
Time frame: Month 3
Triglycerides(mg/dL)
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)
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)
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)
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)
21 secondary outcomes
To evaluate effectiveness from baseline.
Time frame: Month 3, month 6 and month 12
To evaluate effectiveness from baseline.
Time frame: 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
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time frame: 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
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time frame: 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
Analyze cardiometabolic profile changes based on metabolic syndrome factors
Time frame: 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
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time frame: 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
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time frame: 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
Analyze cardiometabolic profile based on other cardiovascular risk factors
Time frame: 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
QTc levels
Time frame: Month 12
Change in weight
Time frame: 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
Health resources use
Time frame: Month 3, month 6 and month 12
Evaluate safety and tolerability
Time frame: through study completion, an average of 1 year
Reason for SGA discontinuation
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Recruitment was not completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Angelini Farmacéutica at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was not completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze cardiometabolic profile changes based on metabolic syndrome factors changes from baseline to visit 2. (time frame: Month 3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.