SchizophreniaPhase 4MARYLUNCT05351736
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2022to 28 Apr 2024
- Phase
- Phase 4
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with schizophrenia with onset in the past 5 years, diagnosed through a structured clinical interview (SCID-5 CV)
- Aged between 18 and 35 years
- Patients requiring treatment with lurasidone (independently from the inclusion in the present study) or that are being treated with lurasidone for 2 weeks maximum.
- no other psychotropic treatment during the 2 weeks preceding the beginning of the study
- Acceptance of the informed consent form for the participation to the study
- For women in childbearing age, negative pregnancy test (urine or blood Beta HCG) performed before the start of the treatment and use of a highly efficient contraceptive method (such as progestin contraceptives, estrogen-progestin contraceptives, IUD, IUS, bilateral fallopian tube blockage, vasectomized partner, sexual abstinence) throughout the duration of the treatment.
- Aged between 18 and 35 years
- Acceptance of the informed consent form for the participation to the study
Who cannot join
- presence of other psychiatric and/or neurological diagnoses
- previous antipsychotic treatment, except for patients that have been treated with other antipsychotics for less than a month and that have not been treated in the two weeks preceding the beginning of the trial, who are considered eligible.
- contraindications to lurasidone treatment (as per summary of product characteristics)
- intellectual disability
- alcool or substance abuse in the previous 6 months
- presence of absolute or relative contraindications to MRI
Show all 19Show fewer
- underage patients
- no negative pregnancy test or no use of a highly efficient contraceptive method
- pregnancy (if a patient becomes pregnant during the course of the study, the subject will be excluded from the study)
- presence of psychiatric and/or neurological disorders
- family history of psychiatric disorders in 1st-degree relatives
- intellectual disability
- other medical conditions at the time of the study
- family history of hereditary neurological diseases
- alcool or substance abuse
- presence of absolute or relative contraindications to MRI
- underage patients
- no negative pregnancy test or no use of a highly efficient contraceptive method
- pregnancy (if a subject becomes pregnant during the course of the study, the subject will be excluded from the study)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Paolo Brambilla, 0255032717, paolo.brambilla@policlinico.mi.it
About this study
The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Treatment with lurasidone
| Study group | Role | What they receive |
|---|---|---|
| Recent-onset schizophrenia | Experimental | Patients diagnosed with schizophrenia with onset in the last 5 years that will be started on lurasidone or that have been on treatment with lurasidone for less than two weeks at the time of enrollment. Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging
Modifications of grey matter volume measuring using magnetic resonance imaging
Measured: Before and at three months of treatment
Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging
Modifications of cortical superficial area measuring using magnetic resonance imaging
Measured: Before and at three months of treatment
Changes in brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging
Modifications of cerebral cortex thickness measuring using magnetic resonance imaging
Measured: Before and at three months of treatment
Changes in myelin integrity measured using magnetic resonance imaging
Modifications of myelinization status measured in terms of myelin water fraction using magnetic resonance imaging
Measured: Before and at three months of treatment
Secondary outcomes (6)
Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS)
Evaluation of changes in Positive and Negative Syndrome Scale with respect to the baseline. The PANSS is a 30-items scale assessing positive, negative, and general psychopathology associated with schizophrenia. Symptom severity for each item is rated in a 7-poing scale (1=absent; 7=extreme).
Measured: once per month during three months of treatment
Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS)
Evaluation of changes in Brief Psychiatric Rating Scale (BPRS) with respect to the baseline. The BPRS is a scale assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. Each symptom construct ranges from 1 (not present) to 7 (extremely severe).
Measured: once per month during three months of treatment
Number of Adverse effects
Number of severe and non severe adverse effects
Measured: three months of treatment
Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S)
Changes in Brief Assessment of Cognition in Schizophrenia (BAC-S) neuropsychological test scores with respect to the baseline. BAC-S is an assessment tool of cognitive function in patients with schizophrenia.
Measured: once per month during three months of treatment
Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
Grey matter volume differences in patients at baseline vs healthy controls
Measured: baseline
Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
Differences in terms of myelin water fraction in patients at baseline vs healthy controls
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start26 Jan 2022
- Primary completion28 Jan 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
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.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Brambilla, Professor, Principal investigator, S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351736
- Sponsor's protocol ID
- 2021-003816-20
- Acronym
- MARYLU
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
- ClinicalTrials.gov ID
- NCT05351736
- Acronym / sponsor ID
- MARYLU / 2021-003816-20
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 28 Jan 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 28 Apr 2022 (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.
The present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. The effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recent-onset schizophrenia | Experimental | Drug: LurasidonePatients diagnosed with schizophrenia with onset in the last 5 years that will be started on lurasidone or that have been on treatment with lurasidone for less than two weeks at the time of enrollment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients diagnosed with schizophrenia with onset in the past 5 years, diagnosed through a structured clinical interview (SCID-5 CV)
- Aged between 18 and 35 years
- Patients requiring treatment with lurasidone (independently from the inclusion in the present study) or that are being treated with lurasidone for 2 weeks maximum.
- no other psychotropic treatment during the 2 weeks preceding the beginning of the study
- Acceptance of the informed consent form for the participation to the study
Key exclusion criteria (19 listed)
- presence of other psychiatric and/or neurological diagnoses
- previous antipsychotic treatment, except for patients that have been treated with other antipsychotics for less than a month and that have not been treated in the two weeks preceding the beginning of the trial, who are considered eligible.
- contraindications to lurasidone treatment (as per summary of product characteristics)
- intellectual disability
- alcool or substance abuse in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidoneTreatment with lurasidone | Drug | Recent-onset schizophrenia |
Primary outcome
Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging
Time frame: Before and at three months of treatment
Modifications of grey matter volume measuring using magnetic resonance imaging
Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging
Time frame: Before and at three months of treatment
Modifications of cortical superficial area measuring using magnetic resonance imaging
Changes in brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging
Time frame: Before and at three months of treatment
Modifications of cerebral cortex thickness measuring using magnetic resonance imaging
Changes in myelin integrity measured using magnetic resonance imaging
Time frame: Before and at three months of treatment
Modifications of myelinization status measured in terms of myelin water fraction using magnetic resonance imaging
6 secondary outcomes
Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: once per month during three months of treatment
Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS)
Time frame: once per month during three months of treatment
Number of Adverse effects
Time frame: three months of treatment
Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S)
Time frame: once per month during three months of treatment
Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
Time frame: baseline
Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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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.
Paolo Brambilla, Professor principal investigator
S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Brambilla, Professor (0255032717, paolo.brambilla@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging (time frame: Before and at three months of treatment). The study lists 4 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 17 Mar 2023.