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

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06060886

Collaborator

Instituto de Salud Carlos III (Other)

244

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Treatment-resistant Schizophrenia Side Effect Lipid Metabolism Disorders Diabetes NAFLD Psychosis	Drug: Aripiprazole Drug: Paliperidone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

244 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First episode of psychosis patients 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 Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence. Drug: Paliperidone Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence

Arm

Intervention/Treatment

Experimental: First episode of psychosis patients

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

Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence.

Drug: Paliperidone

Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence

Outcome Measures

Primary Outcome Measures

Number of patients with a therapeutic response to aripiprazole or paliperidone [3 months]
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).
Number of patients with a therapeutic response to aripiprazole or paliperidone [3 months]
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).

Secondary Outcome Measures

Number of patients with changes in negative symptoms [12 months]
Using Scale for the Assessment of Negative Symptoms (SANS), test made of 25 items that are scored from 1 (absent) to 5 (extreme).
Number of patients with changes in depressive symptoms [12 months]
Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme).
Number of patients with changes in functionality [12 months]
Using Personal and Social Performance scale (PSP), test made of 4 items that are scored from 1 (absent) to 6 (extreme).
Number of patients with changes in quality of life [12 months]
Using EuroQoL, test made of 1 item that are scored from 0 (worst) to 100 (best).
Number of patients with side effects [12 months]
Using UKU Side Effect Rating Scale, test made of 56 items that are scored from 0 (absent) to 3 (extreme).

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.