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

NCT05351736 | Unknown Phase 4

• 1 other identifier: 2021-003816-20
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Before and at three months of treatment

Secondary Outcomes (6)

• Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS)

  once per month during three months of treatment

• Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS)

  once per month during three months of treatment

• Number of Adverse effects

  three months of treatment

• Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S)

  once per month during three months of treatment

• Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging

  baseline

Study Arms (1)

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.

Drug: Lurasidone

Interventions

Lurasidone DRUG

Treatment with lurasidone

Recent-onset schizophrenia

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)
• Aged between 18 and 35 years
• Acceptance of the informed consent form for the participation to 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paolo Brambilla, Professor

  S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Brambilla, Professor

CONTACT

0255032717; paolo.brambilla@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 28, 2022
• Study Start: January 26, 2022
• Primary Completion: January 28, 2024
• Study Completion: April 28, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

IT (1)