Status:
UNKNOWN
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Schizophrenia
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05351736
Start Date
January 26 2022
End Date
April 28 2024
Last Update
March 17 2023
Active Locations (1)
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1
S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122