Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis (SchizOMICS)
EU CTIS ID: 2024-516768-28-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.