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Clinical Trials/2024-516768-28-00
2024-516768-28-00
Not yet recruiting
Phase 4

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

Consorcio Centro De Investigacion Biomedica En Red12 sites in 1 country244 target enrollmentStarted: December 16, 2024Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
244
Locations
12
Primary Endpoint
Therapeutic response to aripiprazole or paliperidone
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

  1. To identify a set of biomarkers using multi-omics techniques to predict the therapeutic response of aripiprazole or paliperidone after 3 months of treatment in patients with a first psychotic episode of the schizophrenia spectrum
  2. To assess the efficacy of aripiprazole or paliperidone at 3 months in reducing psychotic symptoms by defining "responder" to treatment with the PANSS and CGI-S scales
  3. To assess the effectiveness of aripiprazole or paliperidone in the short term in patients with a first psychotic episode of the schizophrenia spectrum through the proportion of discontinuation of the first antipsychotic received (aripiprazole or paliperidone) in the first 3 months of treatment
  4. To assess the long-term effectiveness of aripiprazole or paliperidone in patients with a first psychotic episode of the schizophrenia spectrum through the time to discontinuation of the first antipsychotic received (aripiprazole or paliperidone) during the first year of treatment

Eligibility Criteria

Ages
0 years to 64 years (0-17 Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged between 15 and 40 years.
  • •Patients who live in the area of influence of the site.
  • •Patients who are experiencing their first psychotic episode.
  • •Patients with diagnoses of the schizophrenia spectrum according to DSM-5 (schizophreniform disorder, schizophrenia, schizoaffective disorder, brief psychotic disorder or psychotic disorder not otherwise specified).

Exclusion Criteria

  • •Be on antipsychotic treatment for >6 weeks at the time of study drug randomization.
  • •Patients who meet the DSM-5 criteria for substance dependence (other than tobacco or cannabis).
  • •Patients who meet the DSM-5 criteria for intelectual disability.
  • •Patients with a history of neurological pathology or traumatic brain injury.
  • •Being pregnant.
  • •Chronic treatment (>3 months) with oral or intramuscular corticosteroids or immunosuppressive treatment.

Outcomes

Primary Outcomes

Therapeutic response to aripiprazole or paliperidone

Therapeutic response to aripiprazole or paliperidone

Secondary Outcomes

  • Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline.
  • Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline.
  • Change in negative symptoms assessed with the SANS at 3 and 12 months. Measured as a change in the SANS scale score compared to baseline.
  • Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline.
  • Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline.
  • Change in quality of life at 3 and 12 months. Measured as a change in the visual-analog scale of the EuroQoL scale with respect to baseline.
  • Side effects at 3 and 12 months evaluated with the UKU scale. The total score (number of side effects) and qualitatively each side effect are assessed.
  • Changes at 3 and 12 months in anthropometric measurements (weight, BMI, abdominal circumference), cardiovascular (blood pressure, heart rate) and laboratory tests (glycaemia, lipid profile, prolactin).

Investigators

Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

Projects Department

Scientific

Consorcio Centro De Investigacion Biomedica En Red

Study Sites (12)

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