Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: LATUDA - 37 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER ALU/ALU - 28X1 COMPRESSE (DOSE UNITARIA)
Product Name: Latuda
Product Code: [Lurasidone]
Pharmaceutical Form: Film-coat
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients: - Patients with recent-onset schizophrenia (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients: - Comorbidity with other psychiatric disorders (on the basis of SCID 5- CV) or neurologic disorders; - Previous antipsychotic treatments. However, patients previously stabilised with other antipsychotic drugs will be admitted, provided that they have not been treated for more than one month and in the two weeks prior to enrolment. - Medica history of intellectual disability - Alchol or substances abuse in the last 6 months - Presence of absolute or relative contraindications to the performance of MRI - women with childbearing potential who have not carried out a negative pregnancy test before taking the drug and who are not using an acceptable method of contraception - Pregnant women (if pregnancy occurs during the study, the patient will be excluded from continuing the study). Exclusion criteria for Healthy controls: - History of psychiatric disorders (based on SCID 5- CV) or neurologic disorders - Intellectual disability - Presence of current medical disorders - Family history of hereditary neurological disease - Presence of absolute or relative contraindications to the performance of MRI - Alcohol or substance abuse - Pregnant women (if pregnancy occurs during the study, the patient will be excluded from continuing the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Assess whether the treatment with lurasidone induces a change in brain structure in terms of morphology. - Evaluate the impact of lurasidone on clinical outcome, as described by number of relapses and symptomatology, global functioning and cognitive performances, in schizophrenic patients - evaluate the safety profile of lurasidone - Identify “normal” patterns of global functioning, myelination and cognitive performance by comparing schizophrenic patients before and after treatment with healthy controls.;Primary end point(s): Significant modification of myelination of specific white tracts (Myelin Water Fraction- MWF) after antipsychotic treatment with lurasidone;Timepoint(s) of evaluation of this end point: 3 months;Main Objective: The primary objective is to assess whether the achievement of therapeutic control of the pathology by lurasidone corresponds to a change in brain structure in terms of connectivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Significant brain structure modification (gray matter volumes, superficial cortical area, cortical thickness) after antipsychotic treatment with lurasidone - Evaluation of lurasidone efficacy on clinical outcome measured by variation of the score of psychopathological scales (PANSS and BPRS) and on cognitive performance in terms of variation of the score of neuropsychological scales (BAC-S) after three months of treatment - Evaluation of lurasidone safety profile in terms of number of serious and non-serious AEs related to the treatment with lurasidone. Adverse events will be assessed on the basis of the patient's clinical observation, laboratory tests (e.g. biochemical, haematological, urine tests) or other clinical tests (e.g. ECG, radiological tests, vital signs). - Assessment of grey matter volumes and white matter myelination in terms of Myelin Water Fraction (MWF), in healthy subjects and patients at baseline and after 3-month lurasidone treatment;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Italy
Contacts
Public ContactUOC Psichiatria
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Outcome results
None listed