Diabetes, Lipid Metabolism Disorders, NAFLD, Psychosis, Schizophrenia, Side Effect, Treatment-resistant Schizophrenia
Conditions
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.
Interventions
DRUGAripiprazole
Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence.
DRUGPaliperidone
Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence
Sponsors
Instituto de Salud Carlos III
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a therapeutic response to aripiprazole or paliperidone | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with changes in negative symptoms | 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). |
| Number of patients with changes in depressive symptoms | 12 months | Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme). |
| Number of patients with changes in functionality | 12 months | Using Personal and Social Performance scale (PSP), test made of 4 items that are scored from 1 (absent) to 6 (extreme). |
| Number of patients with changes in quality of life | 12 months | Using EuroQoL, test made of 1 item that are scored from 0 (worst) to 100 (best). |
| Number of patients with side effects | 12 months | Using UKU Side Effect Rating Scale, test made of 56 items that are scored from 0 (absent) to 3 (extreme). |
Contacts
Primary ContactAlba Toll Privat, MD, PhD
Backup ContactProjects Department (CIBER)
Outcome results
None listed