Trials / Unknown
UnknownNCT06060886
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- Sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER) · Other Government
- Sex
- All
- Age
- 15 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Schizophrenia
- Treatment-resistant Schizophrenia
- Side Effect
- Lipid Metabolism Disorders
- Diabetes
- NAFLD
- Psychosis
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2025-06-01
- Completion
- 2025-12-31
- First posted
- 2023-09-29
- Last updated
- 2023-09-29
Source: ClinicalTrials.gov record NCT06060886. Inclusion in this directory is not an endorsement.