Clinical trial NCT05351736: Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
Official title: Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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
* 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.

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
* 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)

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
* 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)

Primary outcomes:
measure: Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging
timeFrame: Before and at three months of treatment
measure: Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging
timeFrame: Before and at three months of treatment
measure: Changes in brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging
timeFrame: Before and at three months of treatment
measure: Changes in myelin integrity measured using magnetic resonance imaging
timeFrame: Before and at three months of treatment
Secondary outcomes:
measure: Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS)
timeFrame: once per month during three months of treatment
measure: Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS)
timeFrame: once per month during three months of treatment
measure: Number of Adverse effects
timeFrame: three months of treatment
measure: Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S)
timeFrame: once per month during three months of treatment
measure: Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
timeFrame: baseline
measure: Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging
timeFrame: baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardy
Study officials:
affiliation: S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
name: Paolo Brambilla, Professor
role: PRINCIPAL_INVESTIGATOR
References: