Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis (SchizOMICS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Consorcio Centro De Investigacion Biomedica En Red

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

16 Dec 2024 → ongoing

Decision date (initial)

2024-12-16

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516768-28-00

EudraCT number

2022-001582-12

ClinicalTrials.gov

NCT06060886

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 6

1. To assess the efficacy of aripiprazole paliperidone at 3 and 12 months in reducing positive psychotic symptoms using the PANSS scale. And reducing negative psychotic symptoms using the PANSS scale
2. To assess the efficacy of aripiprazole paliperidone at 3 and 12 months in reducing negative psychotic symptoms using the SANS scale and in reducing depressive symptoms using the CDSS scale.
3. To assess the efficacy of aripiprazole paliperidone at 3 and 12 months in improving social functionality using the PSP scale.
4. To assess the efficacy of aripiprazole aliperidone at 3 and 12 months in improving quality of life using the EuroQoL scale.
5. To compare the tolerability profile of aripiprazole paliperidone at 3 and 12 months by quantifying side effects with the UKU scale.
6. To compare the changes at 3 and 12 months of aripiprazole paliperidone in anthropometric measurements, cardiovascular and laboratory tests.

Conditions and MedDRA coding

Schizophrenia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged between 15 and 40 years.
2. Patients who live in the area of influence of the site.
3. Patients who are experiencing their first psychotic episode.
4. 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 6

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Therapeutic response to aripiprazole or paliperidone

Secondary endpoints 8

1. Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline.
2. Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline.
3. 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.
4. Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline.
5. Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline.
6. 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.
7. 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.
8. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Consorcio Centro De Investigacion Biomedica En Red

Sponsor organisation

Consorcio Centro De Investigacion Biomedica En Red

Address

Pab 11, Avenida De Monforte De Lemos 3-5 Avenida De Monforte De Lemos 3-5

City

Madrid

Postcode

28029

Country

Spain

Scientific contact point

Organisation

Consorcio Centro De Investigacion Biomedica En Red

Contact name

Projects Department

Public contact point

Organisation

Consorcio Centro De Investigacion Biomedica En Red

Contact name

Projects Department

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications