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

Phase 4

Not yet recruiting

• Conditions: Diabetes; Psychosis; Schizophrenia; Treatment-resistant Schizophrenia; Side Effect; Lipid Metabolism Disorders; NAFLD
• Interventions: Drug: Aripiprazole; Drug: Paliperidone

• Registration Number: NCT06060886
• Lead Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

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:

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Status Verified: 2023-06
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Study Start: 2023-11-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

1. 15-40 years;
2. living in the catchment area;
3. experiencing a first episode of psychosis;
4. no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
5. Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.

Exclusion Criteria

1. meeting DSM-5 criteria for drug dependence;
2. meeting DSM-IV criteria for mental retardation;
3. having a history of neurological disease or head injury.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First episode of psychosis patients	Aripiprazole	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.
First episode of psychosis patients	Paliperidone	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).