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

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Aripiprazole; Drug: Paliperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT06060886

SchizOMICS

Details and patient eligibility

About

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.

Enrollment: 244 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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244 participants in 1 patient group

First episode of psychosis patients

Experimental group

Description:

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.

Treatment:

Drug: Paliperidone

Drug: Aripiprazole