Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
Study Details
Study Description
Brief 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. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Recent-onset schizophrenia 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. |
Drug: Lurasidone
Treatment with lurasidone
|
Outcome Measures
Primary Outcome Measures
- Brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging [Before and at three months of treatment]
Modifications of grey matter volume measuring using magnetic resonance imaging
- Brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging [Before and at three months of treatment]
Modifications of cortical superficial area measuring using magnetic resonance imaging
- Brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging [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 [Before and at three months of treatment]
Modifications of myelinization status measured in terms of myelin water fraction using magnetic resonance imaging
Secondary Outcome Measures
- Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS) [once per month during three months of treatment]
Evaluation of changes in Positive and Negative Syndrome Scale with respect to the baseline
- Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS) [once per month during three months of treatment]
Evaluation of changes in Brief Psychiatric Rating Scale with respect to the baseline
- Number of Adverse effects [three months of treatment]
Number of severe and non severe adverse effects
- Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S) [once per month during three months of treatment]
Changes in Brief Assessment of Cognition in Schizophrenia (BAC-S) neuropsychological test scores with respect to the baseline
- Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging [baseline]
Grey matter volume differences in patients at baseline vs healthy controls
- Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging [baseline]
Differences in terms of myelin water fraction in patients at baseline vs healthy controls
Eligibility Criteria
Criteria
Inclusion Criteria for the experimental arm:
-
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
Exclusion Criteria for the experimental arm:
-
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
-
underage patients
-
pregnancy (if a patient becomes pregnant during the course of the study, the subject will be excluded from the study)
Inclusion criteria for healthy controls:
-
Aged between 18 and 35 years
-
Acceptance of the informed consent form for the participation to the study
Exclusion criteria for healthy controls:
-
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
-
pregnancy (if a subject becomes pregnant during the course of the study, the subject will be excluded from the study)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U.O.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | Italy | 20122 |
Sponsors and Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-003816-20