SchizophreniaPhase 4SchizOMICSNCT06060886
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
A Phase 4 study testing Aripiprazole and Paliperidone in people with Schizophrenia and Treatment-resistant Schizophrenia, run by Consorcio Centro de Investigación Biomédica en Red (CIBER).
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Schizophrenia, Treatment-resistant Schizophrenia, Side Effect
- What is being tested?
- Aripiprazole and Paliperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-40 years;
- living in the catchment area;
- experiencing a first episode of psychosis;
- no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
- Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Who cannot join
- meeting DSM-5 criteria for drug dependence;
- meeting DSM-IV criteria for mental retardation;
- having a history of neurological disease or head injury.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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:
- 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.
- 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.
- 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.
- Conditions
- Schizophrenia, Treatment-resistant Schizophrenia, Side Effect, Lipid Metabolism Disorders, Diabetes, NAFLD
- Being tested
- Aripiprazole, Paliperidone
- Medical subject headings
- Schizophrenia, Schizophrenia, Treatment-Resistant, Lipid Metabolism Disorders, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Oral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence.
PaliperidoneDrug
Oral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aripiprazole; Drug: Paliperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 3 months
Secondary outcomes (5)
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).
Measured: 12 months
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Javier Labad Arias, MD, PhD, Principal investigator, Consorci Sanitari del Maresme, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060886
- Sponsor's protocol ID
- SchizOMICS
- Acronym
- SchizOMICS
- Status last verified
- Jun 2023
- First submitted
- 16 May 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06060886
- Acronym / sponsor ID
- SchizOMICS / SchizOMICS
- Conditions
- Schizophrenia, Treatment-resistant Schizophrenia, Side Effect, Lipid Metabolism Disorders, Diabetes, NAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First episode of psychosis patients | Experimental | Drug: Aripiprazole, Drug: PaliperidoneOperational 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 15-40 years;
- living in the catchment area;
- experiencing a first episode of psychosis;
- no prior treatment with antipsychotic medication or, if previously treated, a total lifetime of adequate antipsychotic treatment of less than 6 weeks;
- Diagnostic and Statistical Manual of Mental Disorders fth Edition (DSM-5) criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Key exclusion criteria (3 listed)
- meeting DSM-5 criteria for drug dependence;
- meeting DSM-IV criteria for mental retardation;
- having a history of neurological disease or head injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleOral dose range 5-30 mg/day (100 mg- 600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence. | Drug | First episode of psychosis patients |
| PaliperidoneOral dose range 3-12 mg/day (150mg-600 CPZeq). Long -acting injectables will be highly recommended in order to certify adherence | Drug | First episode of psychosis patients |
Primary outcome
Number of patients with a therapeutic response to aripiprazole or paliperidone
Time frame: 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).
Number of patients with a therapeutic response to aripiprazole or paliperidone
Time frame: 3 months
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).
5 secondary outcomes
Number of patients with changes in negative symptoms
Time frame: 12 months
Number of patients with changes in depressive symptoms
Time frame: 12 months
Number of patients with changes in functionality
Time frame: 12 months
Number of patients with changes in quality of life
Time frame: 12 months
Number of patients with side effects
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Labad Arias, MD, PhD principal investigator
Consorci Sanitari del Maresme, Hospital de Mataró
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and Paliperidone in people with Schizophrenia and Treatment-resistant Schizophrenia, run by Consorcio Centro de Investigación Biomédica en Red (CIBER).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Toll Privat, MD, PhD (0034 937 41 77 00 ext. 4754, albatollprivat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a therapeutic response to aripiprazole or paliperidone (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.