Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Enrolling; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Lurasidone

Study type: Interventional

Funder types: Other

Identifiers

NCT05351736

2021-003816-20

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Recent-onset schizophrenia

Experimental group

Description:

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.

Treatment:

Drug: Lurasidone