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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Treatment with lurasidone
S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
RECRUITINGChanges 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and at three months of treatment
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).
Time frame: once per month during three months of treatment
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).
Time frame: once per month during three months of treatment
Number of Adverse effects
Number of severe and non severe adverse effects
Time frame: three months of treatment
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.
Time frame: once per month during three months of treatment
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
Time frame: baseline
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
Time frame: baseline
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