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NCT06060886RecruitingPhase 4

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

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Jan 2026

Brief summary (registry, in English)

1. To identify a set of biomarkers using multi-omics techniques to predict the therapeutic response of aripiprazole or paliperidone after 3 months of treatment in patients with a first psychotic episode of the schizophrenia spectrum 2. To assess the efficacy of aripiprazole or paliperidone at 3 months in reducing psychotic symptoms by defining "responder" to treatment with the PANSS and CGI-S scales 3. To assess the effectiveness of aripiprazole or paliperidone in the short term in patients with a first psychotic episode of the schizophrenia spectrum through the proportion of discontinuation of the first antipsychotic received (aripiprazole or paliperidone) in the first 3 months of treatment 4. To assess the long-term effectiveness of aripiprazole or paliperidone in patients with a first psychotic episode of the schizophrenia spectrum through the time to discontinuation of the first antipsychotic received (aripiprazole or paliperidone) during the first year of treatment

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
244 (estimated)
First submitted
26 Nov 2024
Start date
16 Dec 2024
Lead sponsor
Consorcio Centro De Investigacion Biomedica En Red
NCT number
NCT06060886
EU CT number
2024-516768-28-00
EudraCT number
2022-001582-12

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 244
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Be on antipsychotic treatment for >6 weeks at the time of study drug randomization.
  • Chronic treatment (>3 months) with oral or intramuscular corticosteroids or immunosuppressive treatment.

Other illness

  • Patients with a history of neurological pathology or traumatic brain injury.

Other

  • Patients who meet the DSM-5 criteria for substance dependence (other than tobacco or cannabis).
  • Patients who meet the DSM-5 criteria for intelectual disability.
  • Being pregnant.

Who the study is looking for

  • Patients aged between 15 and 40 years.
  • Patients who live in the area of influence of the site.
  • Patients who are experiencing their first psychotic episode.
  • Patients with diagnoses of the schizophrenia spectrum according to DSM-5 (schizophreniform disorder, schizophrenia, schizoaffective disorder, brief psychotic disorder or psychotic disorder not otherwise specified).

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Consorci Sanitari Del Maresme
Coordinator of this site? Confirm its status
MataroSpainRecruiting
Hospital Universitario Central De Asturias
Coordinator of this site? Confirm its status
OviedoSpainRecruiting
Institut Pere Mata S.A.
Coordinator of this site? Confirm its status
ReusSpainRecruiting
Parc Tauli Hospital Universitari
Coordinator of this site? Confirm its status
SabadellSpainRecruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Complexo Hospitalario Universitario De Vigo
Coordinator of this site? Confirm its status
VigoSpainRecruiting
Hospital Universitario Araba
Coordinator of this site? Confirm its status
VitoriaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.