Clinical Trials Register

Summary
EudraCT Number:	2022-001582-12
Sponsor's Protocol Code Number:	4
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2023-01-16
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2022-001582-12

A.3

Full title of the trial

Open, multicenter, randomized clinical trial to evaluate the efficacy and safety of aripiprazole vs paliperidone / risperidone using multi-omics data in patients with a first psychotic episode.

Ensayo clínico abierto, multicéntrico, aleatorizado para evaluar la eficacia y seguridad de aripiprazol vs paliperidona / risperidona mediante datos multi-ómicos en pacientes con un primer episodio psicótico.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Open, multicenter, randomized clinical trial to evaluate the efficacy and safety of aripiprazole vs paliperidone / risperidone using multi-omics data in patients with a first psychotic episode.

A.3.2

Name or abbreviated title of the trial where available

SchizOMICS

A.4.1

Sponsor's protocol code number

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Consorcio Centro de Investigacion Biomedica en Red (CIBER)
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Instituto de Salud Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Consorcio Centro de Investigacion Biomedica en Red (CIBER)
B.5.2	Functional name of contact point	Rebeca Colorado
B.5.3	Address:
B.5.3.1	Street Address	Instituto de Salud Carlos III. Av. Monforte de Lemos, 5. Pabellon 11
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28029
B.5.3.4	Country	Spain
B.5.6	E-mail	proyectos@ciberisciii.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Abilify Maintena
D.2.1.1.2	Name of the Marketing Authorisation holder	Abilify Maintena
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xeplion
D.2.1.1.2	Name of the Marketing Authorisation holder	Xeplion
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

First episode SZ-spectrum individuals

Pacientes con un primer episodio psicótico

E.1.1.1

Medical condition in easily understood language

First episode SZ-spectrum individuals

Pacientes con un primer episodio psicótico

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

1. Identificar un set de biomarcadores mediante técnicas multi-ómicas que permita predecir la respuesta terapéutica de aripiprazol o paliperidona a los 3 meses de tratamiento en pacientes con un primer episodio psicótico del espectro de la esquizofrenia
2. Valorar la eficacia de aripiprazol o paliperidona a los 3 meses en la reducción de sintomatología psicótica mediante la definición de “respondedor” al tratamiento con las escalas PANSS y CGI-S
3. Valorar la efectividad de aripiprazol o paliperidona a corto plazo mediante la proporción de discontinuación del primer antipsicótico recibido (aripiprazol o paliperidona) en los 3 primeros meses de tratamiento
4. Valorar la efectividad de aripiprazol o paliperidona a largo plazo mediante el tiempo hasta la discontinuación del primer antipsicótico recibido (aripiprazol o paliperidona) durante el primer año de tratamiento

E.2.2

Secondary objectives of the trial

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

1. Eficacia de aripiprazol paliperidona a los 3 y 12 meses en la reducción de síntomas psicóticos positivos mediante la esc PANSS y reducción de síntomas psicóticos negativos mediante la esc PANSS
2. Eficacia de aripiprazol paliperidona a los 3 y 12 meses en la reducción de síntomas psicóticos negativos mediante la esc SANS y reducción de síntomas depresivos mediante la esc CDSS
3. Valorar la eficacia de aripiprazol o paliperidona a los 3 y 12 meses en la mejoría en funcionalidad social mediante la escala PSP
4. Eficacia de aripiprazol o paliperidona a los 3 y 12 meses en la mejoría en calidad de vida mediante la escala EuroQoL
5. Comparar el perfil de tolerabilidad de aripiprazol o paliperidona a los 3 y 12 meses mediante la cuantificación de efectos secundarios con la escala UKU
6. Comparar los cambios a los 3 y 12 meses de aripiprazol o paliperidona en medidas antropométricas, cardiovasculares y analíticas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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).

1. Pacientes con edad comprendida entre 15 y 40 años.
2. Pacientes que vivan en el área de influencia del centro.
3. Pacientes que estén experimentando su primer episodio psicótico.
4. Pacientes con diagnósticos del espectro de la esquizofrenia según DSM-5 (trastorno esquizofreniforme, esquizofrenia, trastorno esquizoafectivo, trastorno psicótico breve o trastorno psicótico no especificado).

E.4

Principal exclusion criteria

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 intellectual 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.

1. Estar recibiendo tratamiento antipsicótico desde hace >6 semanas en el momento de la aleatorización del fármaco de estudio.
2. Pacientes que cumplan los criterios del DSM-5 para dependencia a sustancias (diferente a tabaco o cannabis).
3. Pacientes que cumplan los criterios del DSM-5 para discapacidad intelectual.
4. Pacientes con antecedentes de patología neurológica o traumatismo craneoencefálico.
5. Estar embarazada.
6. Tratamiento crónico (>3 meses) con corticoides orales o intramusculares o tratamiento inmunosupresor.

E.5 End points

E.5.1

Primary end point(s)

Therapeutic response to aripiprazole or paliperidone

Respuesta terapéutica a aripiprazol o paliperidona

E.5.1.1

Timepoint(s) of evaluation of this end point

Time to discontinuation of the first antipsychotic (time). The time to discontinuation in the first year of follow-up will be considered.

Tiempo hasta la discontinuación del primer antipsicótico (tiempo). Se considerará el tiempo hasta la discontinuación en el primer año de seguimiento.

E.5.2

Secondary end point(s)

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).

Cambio en síntomas psicóticos positivos a los 3 y a los 12 meses. Medido como cambio en la puntuación de la subescala PANSS de síntomas positivos respecto a la basal.
Cambio en síntomas negativos evaluados con la PANSS a los 3 y a los 12 meses. Medido como cambio en la puntuación de la subescala PANSS de síntomas negativos respecto a la basal.
Cambio en síntomas negativos evaluados con la SANS a los 3 y a los 12 meses. Medido como cambio en la puntuación de la escala SANS respecto a la basal.
Cambio en síntomas depresivos a los 3 y a los 12 meses. Medido como cambio en la puntuación de la escala CDS respecto a la basal.
Cambio en funcionalidad a los 3 y a los 12 meses. Medido como cambio en la puntuación de la escala PSP respecto a la basal.
Cambio en la calidad de vida a los 3 y a los 12 meses. Medido como cambio en la escala analógica-visual de la escala EuroQoL respecto a la basal.
Efectos secundarios a los 3 y 12 meses evaluados con la escala UKU. Se valora la puntuación total (número de efectos secundarios) y cualitativamente cada efecto secundario.
Cambios a los 3 y a los 12 meses en medidas antropométricas (peso, IMC, perímetro abdominal), cardiovasculares (tensión arterial, frecuencia cardíaca) y analíticas (glicemia, perfil lipídico, prolactina).

E.5.2.1

Timepoint(s) of evaluation of this end point

At 3 and 12 months

A los 3 y 12 meses

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Evaluación de la eficacia y seguridad de aripiprazol vs paliperidona / risperidona mediante datos multi-ómicos en pacientes con un primer episodio psicótico.

Evaluation of the efficacy and safety of aripiprazole vs paliperidone/risperidone using multi-omics data in patients with a first psychotic episode.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Aripiprazol vs Paliperidona/Risperidona

Aripiprazole vs Paliperidone/Risperidone

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LPLV

Visita final del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

224

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

244

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-03-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-30

P. End of Trial
P.	End of Trial Status	Ongoing

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