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

NCT ID: NCT06060886

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

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

Paliperidone

Intervention Type DRUG

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

Interventions

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Aripiprazole

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

Intervention Type DRUG

Paliperidone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Labad Arias, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari del Maresme, Hospital de Mataró

Central Contacts

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Alba Toll Privat, MD, PhD

Role: CONTACT

Phone: 0034 937 41 77 00

Email: [email protected]

Projects Department (CIBER)

Role: CONTACT

Phone: +34918222874

Email: [email protected]

Other Identifiers

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SchizOMICS

Identifier Type: -

Identifier Source: org_study_id