SchizOMICS is a Phase IV, multicenter, dose-flexible, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of aripiprazole versus paliperidone using multi-omics data in patients with a first psychotic episode. The trial will include a total of 244 patients, with two arms of treatment with paliperidone and aripiprazole (1:1). The main objectives of the study are: 1. To compare the efficacy and safety of aripiprazole and paliperidone in the treatment of first episode psychosis (FEP) subjects in real-world clinical settings at 3 months. 2. To elucidate whether non-responders after 3 months of adequate treatment may display different molecular signatures at baseline based on multi omics data and systems biology analysis. 3. To uncover whether the appearance of side effects after 1 year of adequate treatment may be related to different molecular signatures based on multi-omics data and lifestyle phenotype using systems biology analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence.
Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence
Number of patients with a therapeutic response to aripiprazole or paliperidone
Considering response as a reduction in the Positive and Negative Symptom Scale (PANSS) \> 50%. PANSS is a test made up of 30 items that are scored from 1 (absent) to 7 (extreme).
Time frame: 3 months
Number of patients with a therapeutic response to aripiprazole or paliperidone
Considering response as Clinical Global Impression severity scale for schizophrenia (ICG-ESQ-SI) \< 4 points. ICG-ESQ-SI is a test made of 5 items that are scored from 1 (absent) to 7 (extreme).
Time frame: 3 months
Number of patients with changes in negative symptoms
Using Scale for the Assessment of Negative Symptoms (SANS), test made of 25 items that are scored from 1 (absent) to 5 (extreme).
Time frame: 12 months
Number of patients with changes in depressive symptoms
Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme).
Time frame: 12 months
Number of patients with changes in functionality
Using Personal and Social Performance scale (PSP), test made of 4 items that are scored from 1 (absent) to 6 (extreme).
Time frame: 12 months
Number of patients with changes in quality of life
Using EuroQoL, test made of 1 item that are scored from 0 (worst) to 100 (best).
Time frame: 12 months
Number of patients with side effects
Using UKU Side Effect Rating Scale, test made of 56 items that are scored from 0 (absent) to 3 (extreme).
Time frame: 12 months
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