Clinical trial NCT06060886: Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Schizophrenia
Treatment-resistant Schizophrenia
Side Effect
Lipid Metabolism Disorders
Diabetes
NAFLD
Psychosis
Lead sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-09-29
Enrollment: 244
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a therapeutic response to aripiprazole or paliperidone
timeFrame: 3 months
measure: Number of patients with a therapeutic response to aripiprazole or paliperidone
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients with changes in negative symptoms
timeFrame: 12 months
measure: Number of patients with changes in depressive symptoms
timeFrame: 12 months
measure: Number of patients with changes in functionality
timeFrame: 12 months
measure: Number of patients with changes in quality of life
timeFrame: 12 months
measure: Number of patients with side effects
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Consorci Sanitari del Maresme, Hospital de Mataró
name: Javier Labad Arias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: