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

September 27, 2023 updated by: Consorcio Centro de Investigación Biomédica en Red (CIBER)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Drug: Paliperidone
Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with a therapeutic response to aripiprazole or paliperidone
Time Frame: 3 months

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
Time Frame: 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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with changes in negative symptoms
Time Frame: 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).
12 months
Number of patients with changes in depressive symptoms
Time Frame: 12 months
Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme).
12 months
Number of patients with changes in functionality
Time Frame: 12 months
Using Personal and Social Performance scale (PSP), test made of 4 items that are scored from 1 (absent) to 6 (extreme).
12 months
Number of patients with changes in quality of life
Time Frame: 12 months
Using EuroQoL, test made of 1 item that are scored from 0 (worst) to 100 (best).
12 months
Number of patients with side effects
Time Frame: 12 months
Using UKU Side Effect Rating Scale, test made of 56 items that are scored from 0 (absent) to 3 (extreme).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Javier Labad Arias, MD, PhD, Consorci Sanitari del Maresme, Hospital de Mataró

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SchizOMICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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