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

Schizophrenia Clinical Trial

— MARYLU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351736
• Other study ID #: 2021-003816-20
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2022
• Est. completion date: April 28, 2024

Study information

• Verified date: March 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Paolo Brambilla, Professor
• Phone: 0255032717
• Email: paolo.brambilla[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

Intervention

Drug:
• Lurasidone
Treatment with lurasidone

Locations

Country	Name	City	State
Italy	S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	once per month during three months of treatment
Secondary	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).	once per month during three months of treatment
Secondary	Number of Adverse effects	Number of severe and non severe adverse effects	three months of treatment
Secondary	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.	once per month during three months of treatment
Secondary	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	baseline
Secondary	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	baseline