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

NCT06060886 | Unknown Phase 4 DMC

• 1 other identifier: SchizOMICS
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of patients with changes in negative symptoms

  12 months

• Number of patients with changes in depressive symptoms

  12 months

• Number of patients with changes in functionality

  12 months

• Number of patients with changes in quality of life

  12 months

• Number of patients with side effects

  12 months

Study Arms (1)

First episode of psychosis patients

EXPERIMENTAL

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; Drug: Paliperidone

Interventions

Aripiprazole DRUG

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

First episode of psychosis patients

Paliperidone DRUG

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

First episode of psychosis patients

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Treatment-Resistant; Lipid Metabolism Disorders; Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Psychotic Disorders

Interventions

Aripiprazole; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isoxazoles; Azoles; Pyrimidines

Study Officials

• Javier Labad Arias, MD, PhD

  Consorci Sanitari del Maresme, Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Toll Privat, MD, PhD

CONTACT

0034 937 41 77 00; albatollprivat@gmail.com

Projects Department (CIBER)

CONTACT

+34918222874; proyectos@ciberisciii.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: September 29, 2023
• Study Start: November 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share