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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | Treatment with lurasidone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for the experimental arm:
Exclusion Criteria for the experimental arm:
Inclusion criteria for healthy controls:
Exclusion criteria for healthy controls:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Brambilla, Professor | Contact | 0255032717 | paolo.brambilla@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Brambilla, Professor | S. C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.C. Psichiatria - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20122 | Italy |
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| 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 |
| Number of Adverse effects | Number of severe and non severe adverse effects | 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. | 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 | 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 | baseline |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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