Status:
UNKNOWN
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
Lead Sponsor:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Schizophrenia
Treatment-resistant Schizophrenia
Eligibility:
All Genders
15-40 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 15-40 years;
- living in the catchment area;
- experiencing a first episode of psychosis;
- no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
- Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Exclusion
- meeting DSM-5 criteria for drug dependence;
- meeting DSM-IV criteria for mental retardation;
- having a history of neurological disease or head injury.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06060886
Start Date
November 1 2023
End Date
December 31 2025
Last Update
September 29 2023
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