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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06060886
Other study ID # SchizOMICS
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2025

Study information

Verified date June 2023
Source Consorcio Centro de Investigación Biomédica en Red (CIBER)
Contact Alba Toll Privat, MD, PhD
Phone 0034 937 41 77 00
Email albatollprivat@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 244
Est. completion date December 31, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 40 Years
Eligibility 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.

Study Design


Intervention

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.
Paliperidone
Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Consorcio Centro de Investigación Biomédica en Red (CIBER) Instituto de Salud Carlos III

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Number of patients with changes in depressive symptoms Using Calgary Depression Scale for Schizophrenia (CDSS), test made of 9 items that are scored from 1 (absent) to 4 (extreme). 12 months
Secondary 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
Secondary 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
Secondary 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
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