Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis

Study Overview
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Brief Summary
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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: 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. 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. 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.

Official Title
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Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis

Conditions
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Schizophrenia, Treatment-resistant Schizophrenia, Side Effect, Lipid Metabolism Disorders, Diabetes, NAFLD, Psychosis

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Paliperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15-40 years; living in the catchment area; experiencing a first episode of psychosis; no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks; Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder. Exclusion Criteria: meeting DSM-5 criteria for drug dependence; meeting DSM-IV criteria for mental retardation; having a history of neurological disease or head injury.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First episode of psychosis patients<br>Operational definition for a first episode of psychosis included individuals with a non-affective psychosis who have not received previous antipsychotic treatment regardless of the duration of psychosis. | Drug: Aripiprazole<br>* Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence.<br>Drug: Paliperidone<br>* Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 12 months |