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

Schizophrenia Clinical Trial

— SchizOMICS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06060886
• Other study ID #: SchizOMICS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Contact: Alba Toll Privat, MD, PhD
• Phone: 0034 937 41 77 00
• Email: albatollprivat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 244
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Lipid Metabolism Disorders
• Mental Disorders
• Metabolic Diseases
• NAFLD
• Psychosis
• Psychotic Disorders
• Schizophrenia
• Side Effect
• Treatment-resistant Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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