Schizophrenia
Conditions
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.
Interventions
DRUGLurasidone
Treatment with lurasidone
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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). |
| Number of Adverse effects | three months of treatment | Number of severe and non severe adverse effects |
| 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. |
Countries
Italy
Contacts
Primary ContactPaolo Brambilla, Professor
Outcome results
None listed