Clinical Trials Register

Summary
EudraCT Number:	2013-001315-71
Sponsor's Protocol Code Number:	DPSANARI2012
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:	2013-06-26
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

2013-001315-71

A.3

Full title of the trial

Dopaminergic genotype of schizophrenic patients and the benefit of adjunctive aripiprazole to risperidone treatment. The effect on hormonal and metabolic measures

Perfil dopaminérgico de los pacientes esquizofrénicos que se beneficiarán de la adición de aripiprazol al tratamiento con risperidona/paliperidona. Efecto sobre parámetros hormonales y metabólicos

A.3.1

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

Dopaminergic genotype of schizophrenic patients and the benefit of adjunctive aripiprazole to risperidone treatment. The effect on hormonal and metabolic measures

A.4.1

Sponsor's protocol code number

DPSANARI2012

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	Mercedes Zumarraga Ortiz
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	Fundación Vasca de Investigación Sanitaria (Bioef)
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	Mercedes Zumarraga Ortiz
B.5.2	Functional name of contact point	Mercedes Zumarraga Ortiz
B.5.3	Address:
B.5.3.1	Street Address	Arteaga Auzoa 45
B.5.3.2	Town/ city	Zamudio
B.5.3.3	Post code	48170
B.5.3.4	Country	Spain
B.5.4	Telephone number	3494400 6519
B.5.5	Fax number	34944006526
B.5.6	E-mail	mercedes.zumarragaortiz@osakidetza.net

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
D.2.1.1.2	Name of the Marketing Authorisation holder	Otsuka Pharmaceutical Europe Ltd.
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	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ARIPIPRAZOLE
D.3.9.1	CAS number	129722-12-9
D.3.9.4	EV Substance Code	SUB05564MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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

schizophrenia

Esquizofrenia

E.1.1.1

Medical condition in easily understood language

schizophrenia

Esquizofrenia

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Psychological processes [F02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10039626
E.1.2	Term	Schizophrenia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

2.- Observar el comportamiento de los valores de prolactina y parámetros metabólicos al cabo de 1 y 4 semanas, tras añadir 5mg de aripiprazol al tratamiento estable con risperidona/paliperidona.

3.- Valorar si hay una relación entre el perfil genético y el neuroquímico, y las variaciones en prolactina y factores metabólicos con el tratamiento combinado de risperidona/paliperidona y aripiprazol.

4.- Comprobar los puntos anteriores según el sexo, la edad y el perfil clínico de los pacientes.

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Pacientes diagnosticados de trastorno esquizofrénico (n=110) según el DSM-IV-TR, a través de la entrevista estructurada SCID, de ambos sexos, edad entre 18 y 65 años, de origen caucásico y que lleven, al inicio del estudio, 1 semana al menos de tratamiento con risperidona/paliperidona.

E.4

Principal exclusion criteria

embarazo, lactancia, enfermedades endocrino-metabólicas y dependencia de tóxicos. Los pacientes se incluirán en el estudio tras ser informados por su Psiquiatra y después de firmar, ellos mismos o su tutor legal, un consentimiento escrito.
El estudio se realizará a ciego simple hasta el momento de los análisis de los resultados. El personal del laboratorio de Neuroquímica desconocerá la identidad del paciente, el momento del tratamiento y el estado psicopatológico. A su vez los Psiquiatras desconocerán los valores hormonales, neuroquímicos, metabólicos y genéticos de las muestras.

E.5 End points

E.5.1

Primary end point(s)

Variables socio-demográficas y clínicas: se recogerán los datos demográficos y los referentes a la edad de inicio, ajuste premórbido, sintomatología predominante de la enfermedad, historia familiar de la enfermedad, síntomas de hiperprolactinemia y menopausia. También la dosis y duración del tratamiento con risperidona/paliperidona y otros tratamientos, así como los cambios que se produzcan. Los pacientes se valorarán psicopatológicamente mediante las escalas CGI, SAPS Y SANS.

Variables genéticas: El ADN se extraerá de sangre total utilizando un kit comercial. Los polimorfismos genéticos Taq1A e -141C Ins/Del del gen D2R y el ValMet de COMT se valorarán mediante PCR a tiempo real utilizando sondas TaqMan.

Variables hormonales y metabólicas: la prolactina e insulina se valorarán mediante ELISA. Los lípidos y glucosa sanguíneos mediante las técnicas estandar del laboratorio de análisis clínicos.

Variables neuroquímicas: se valorarán las concentraciones plasmáticas de dos metabolitos de la dopamina, el ácido homovainíllico y el ácido 3,4-dihidroxifenilacético. Se analizarán por cromatografía líquida con detección culombimétrica y amperométrica respectivamente, mediante técnicas desarrolladas en el Dpto. de Investigación Neuroquímica.

E.5.1.1

Timepoint(s) of evaluation of this end point

Al final del estudio

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

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

E.8.1.1

Randomised

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

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

LVLP

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

110

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

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In the whole clinical trial

110

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

2013-10-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-01

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

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