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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First episode of psychosis patients | Experimental | Operational definition for a "first episode of psychosis" included individuals with a non-affective psychosis who have not received previous antipsychotic treatment regardless of the duration of psychosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a therapeutic response to aripiprazole or paliperidone | 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). | 3 months |
| Number of patients with a therapeutic response to aripiprazole or paliperidone | Considering response as Clinical Global Impression severity scale for schizophrenia (ICG-ESQ-SI) < 4 points. ICG-ESQ-SI is a test made of 5 items that are scored from 1 (absent) to 7 (extreme). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with changes in negative symptoms | Using Scale for the Assessment of Negative Symptoms (SANS), test made of 25 items that are scored from 1 (absent) to 5 (extreme). | 12 months |
| Number of patients with changes in depressive symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alba Toll Privat, MD, PhD | Contact | 0034 937 41 77 00 | 4754 | albatollprivat@gmail.com |
| Projects Department (CIBER) | Contact | +34918222874 | proyectos@ciberisciii.es |
| Name | Affiliation | Role |
|---|---|---|
| Javier Labad Arias, MD, PhD | Consorci Sanitari del Maresme, Hospital de Mataró | Principal Investigator |
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| Paliperidone | Drug | Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence |
|
Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme).
| 12 months |
| Number of patients with changes in functionality | Using Personal and Social Performance scale (PSP), test made of 4 items that are scored from 1 (absent) to 6 (extreme). | 12 months |
| Number of patients with changes in quality of life | Using EuroQoL, test made of 1 item that are scored from 0 (worst) to 100 (best). | 12 months |
| Number of patients with side effects | Using UKU Side Effect Rating Scale, test made of 56 items that are scored from 0 (absent) to 3 (extreme). | 12 months |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000090663 | Schizophrenia, Treatment-Resistant |
| D052439 | Lipid Metabolism Disorders |
| D003920 | Diabetes Mellitus |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D011743 | Pyrimidines |
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