Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
- Registration Number
- NCT05351736
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recent-onset schizophrenia Lurasidone 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.
- Primary Outcome Measures
Name Time Method Changes in brain structural modifications in terms of cortical superficial area measured using magnetic resonance imaging Before and at three months of treatment Modifications of cortical superficial area measuring using magnetic resonance imaging
Changes in brain structural modifications in terms of cerebral cortex thickness measuring using magnetic resonance imaging Before and at three months of treatment Modifications of cerebral cortex thickness measuring using magnetic resonance imaging
Changes in myelin integrity measured using magnetic resonance imaging Before and at three months of treatment Modifications of myelinization status measured in terms of myelin water fraction using magnetic resonance imaging
Changes in brain structural modifications in terms of grey matter volume measured using magnetic resonance imaging Before and at three months of treatment Modifications of grey matter volume measuring using magnetic resonance imaging
- Secondary Outcome Measures
Name Time Method Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale (BPRS) once per month during three months of treatment 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).
Structural differences in patients at baseline vs healthy controls measured using magnetic resonance imaging baseline Grey matter volume differences in patients at baseline vs healthy controls
Evaluation of efficacy as assessed by Positive and Negative Syndrome Scale (PANSS) once per month during three months of treatment 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).
Changes in cognitive performance as assessed by Brief Assessment of Cognition in Schizophrenia (BAC-S) once per month during three months of treatment 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.
Number of Adverse effects three months of treatment Number of severe and non severe adverse effects
Myelinization differences in patients at baseline vs healthy controls measured using magnetic resonance imaging baseline Differences in terms of myelin water fraction in patients at baseline vs healthy controls
Trial Locations
- Locations (1)
S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Lombardy, Italy