Clinical Trials Register

Summary
EudraCT Number:	2009-016245-26
Sponsor's Protocol Code Number:	H8Y-MC-HBCO
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-11-24
Trial results	View 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

2009-016245-26

A.3

Full title of the trial

Estudio de Fase 2, de 17 Semanas, Multicéntrico, Aleatorizado y Doble Ciego, Sobre la Eficacia de LY2140023 Combinado con Tratamiento Clínico Habitual Comparado con Placebo Combinado con Tratamiento Clínico Habitual, en Pacientes con Esquizofrenia con Síntomas Negativos Prominentes

A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment with LY2140023 Combined with Standard of Care Compared to Placebo Combined with Standard of Care in the Treatment of Patients with Prominent Negative Symptoms of Schizophrenia

A.3.2

Name or abbreviated title of the trial where available

HBCO

A.4.1

Sponsor's protocol code number

H8Y-MC-HBCO

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Lilly S.A
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	No
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.3.1	Product name	mGlu2/3 Agonist Prodrug II
D.3.2	Product code	LY2140023
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	635318-55-7
D.3.9.2	Current sponsor code	LY2140023
D.3.9.3	Other descriptive name	mGlu2/3 Agonist Prodrug II
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	10
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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	No
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.3.1	Product name	mGlu2/3 Agonist Prodrug II
D.3.2	Product code	LY2140023
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	635318-55-7
D.3.9.2	Current sponsor code	LY2140023
D.3.9.3	Other descriptive name	mGlu2/3 Agonist Prodrug II
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	20
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 3
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	No
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.3.1	Product name	mGlu2/3 Agonist Prodrug II
D.3.2	Product code	LY2140023
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	635318-55-7
D.3.9.2	Current sponsor code	LY2140023
D.3.9.3	Other descriptive name	mGlu2/3 Agonist Prodrug II
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	40
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 4
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	ZYPREXA 5 mg comprimidos recubiertos
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NETHERLAND BV
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	OLANZAPINA
D.3.9.3	Other descriptive name	OLANZAPINE
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 5
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	ABILIFY 15 mg comprimidos
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	Information not present in EudraCT
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	ARIPIPRAZOL
D.3.9.3	Other descriptive name	ARIPIPRAZOLE
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	15
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 6
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	ABILIFY 10 mg comprimidos
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	Information not present in EudraCT
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	ARIPIPRAZOL
D.3.9.3	Other descriptive name	ARIPIPRAZOLE
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	10
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 7
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	RISPERDAL 1 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	RISPERIDONA
D.3.9.3	Other descriptive name	RISPERIDONA
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	2
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 8
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	RISPERDAL, 3 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	RISPERIDONA
D.3.9.3	Other descriptive name	RISPERIDONA
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	3
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 9
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	SEROQUEL 200 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA FARMACEUTICA SPAIN, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	QUETIAPINA FUMARATO
D.3.9.3	Other descriptive name	QUETIAPINE FUMARATE
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	200
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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: 10
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	SEROQUEL 300 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA FARMACEUTICA SPAIN, S.A.
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	QUETIAPINA FUMARATO
D.3.9.3	Other descriptive name	QUETIAPINE FUMARATE
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	300
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Esquizofrenia

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10039626
E.1.2	Term	Schizophrenia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal de este estudio es evaluar la hipótesis de que el tratamiento con LY2140023 en comparación con placebo, cuando se administran como tratamiento adicional a una dosis fija del tratamiento de referencia (TdR) con un antipsicótico, mostrará una reducción significativamente mayor de los síntomas negativos, según se determina mediante la Escala para la Evaluación de los Síntomas Negativos de 16 ítems (NSA-16), en pacientes con esquizofrenia. En este estudio se incluirán pacientes que estén recibiendo de forma concomitante 1 de los siguientes 4 antipsicóticos atípicos: aripiprazol, olanzapina, risperidona o quetiapina.

E.2.2

Secondary objectives of the trial

-LY2140023 (+ tto de ref) demuestra una > mejoría sintomática frente placebo (+ tto de ref.), según PANSS.
-LY2140023 (+ tto de ref.) demuestra una > mejoría sintomática frente placebo (+ tto de ref.), según la Subescala + PANSS y CGI-S.
-LY2140023 (+ el tto de ref.) demuestra mejoría cognitiva y funcional, frente placebo (+ el tto de ref.), según la MCCB y UPSA-B.
-LY2140023 (+ el tto de ref.) demuestra una > mejoría los resultados de salud, comparado con placebo (+ el tto de ref.), según: la PSP, el S-RUM, la SWN-S y el EQ-5D.
-Seguridad y tolerabilidad de LY2140023 (+ el tto de ref.), comparado con placebo (+ el tto de ref.), según: AAST, SEP, EEG, ECG, examen neurológico, const vitales, peso, analíticas y evaluación de los AAS relac con el suicidio, mediante la C-SSRS.
-Efectividad global del tratamiento con LY2140023 (+ tto de ref.), comparado con placebo (+ tto de ref.), según tasa de discont por cualquier motivo, tasa de discont por falta eficacia y tasa discont por AAs

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

[1] Pacientes de ambos sexos, de edades comprendidas entre 18 y 65 años (ambos inclusive) en el momento de inclusión en el estudio, con diagnóstico de esquizofrenia, de acuerdo con la cuarta Edición del Manual diagnóstico y estadístico de los Trastornos Mentales, texto revisado (DSM-IV-TR) (Desorganizado, 295.10; Catatónico, 295.20; Paranoide 295.30; Residual, 295.60; o indeferenciado, 295.90), y confirmado mediante la Entrevista Clínica Estructurada para DSM-IV (SCID).
[2] Las pacientes deberán presentar un resultado negativo en una prueba de embarazo que se realizará en la visita 1, y estar de acuerdo en utilizar durante el estudio un método anticonceptivo fiable.
[3] Los pacientes deberán presentar una puntuación ≤ 60 en la Evaluación Global de Funcionamiento (GAF), en el cribado y hasta la visita 4.
[4] Los pacientes deberán presentar una puntuación ≥ 4 en al menos 3 de los 7 ítems que valoran síntomas negativos de la subescala Marder de la PANSS (Marder et al. 1997), o ≥ 5 en al menos 2 de dichos 7 ítems que valoran síntomas negativos (embotamiento afectivo, retraimiento emocional, contacto pobre, retraimiento social (comportamiento apático/pasivo), enlentecimiento motor, falta de espontaneidad y fluidez en la conversación, evitación social activa), en el cribado y hasta la visita 4.
[5] Asimismo, los pacientes deben:
• Estar dispuestos a poder ser hospitalizados, o permanecer hospitalizados (si ya están hospitalizados), durante aproximadamente 2 semanas (las primeras 1 ó 2 semanas del tratamiento combinado). A los efectos de este estudio, la hospitalización se define como un ingreso en el hospital u otra clínica.
• Presentar una situación clínica tal que el investigador, según su juicio clínico, considere en el momento del reclutamiento que podrá recibir el alta hospitalaria en la visita 5, después de las primeras 1 ó 2 semanas de tratamiento combinado.
[6] Haber estado recibiendo un tratamiento en monoterapia al menos durante los 3 meses previos a la inclusión en el estudio, con uno de los 4 antipsicóticos atípicos que constituyen el tratamiento de referencia en este estudio (aripiprazol, olanzapina, risperidona, o quetiapina), y haber estado recibiendo una dosis fija del mismo al menos durante las 2 semanas previas a la inclusión en el estudio.
[7] Presentar síntomas estables de esquizofrenia. La estabilidad sintomática se verificará en el período comprendido entre la visita 1 y la aleatorización al tratamiento adicional (visita 3 ó 4). Asimismo, no deberán presentar, entre la visita 1 y la visita 4, un cambio en la puntuación total de la PANSS mayor del 25% (la evaluación deberá llevarse a cabo por evaluadores enmascarados).
[8] Ser capaces de comprender la naturaleza del estudio, y haber proporcionado el consentimiento informado.
[9] Los pacientes deberán recibir una dosis fija del TdR entre la visita 1 y la visita 3, y deberán continuar recibiendo dicha dosis durante el resto del estudio.

E.4

Principal exclusion criteria

[10] Personal del centro de investigación, y/o familiares cercanos.
[11] Ser empleado de Lilly.
[12] Estar participando o haber abandonado en los últimos 30 días un ensayo clínico, u otro tipo de investigación médica no compatible.
[13] Haber completado o haber sido retirado del estudio, o de cualquier ensayo en el que se investigue LY2140023
[14] Presentar en la actualidad cualquier otro trastorno psiquiátrico del eje I (excepto esquizofrenia), según el DSM-IV-TR.
[15] Pacientes con tratamiento con LY2140023 contraindicado clínicamente.
[16] Pacientes que requieran tratamiento concomitante con cualquier otra medicación con actividad sobre el SNC.
[17] Pacientes que estén recibiendo tratamiento concomitante con un antipsicótico de liberación prolongada.
[18] Pacientes que hayan recibido tratamiento con clozapina, o que hayan recibido cualquier dosis de clozapina durante los 3 meses previos a la v1.
[19] Respuesta afirmativa en la pregunta 4 o 5, en la sección de "Ideación suicida" del C-SSRS, o ha contestado afirmativamente a cualquier de los comportamientos suicidas, en la sección "Comportamiento suicida" del cuestionario C-SSRS, y dicha ideación o comportamiento se ha producido en el último mes.
[20] Pacientes con diagnóstico según DSM-IV-TR de abuso o dependencia de sustancias desde 6 meses antes V1.
[21] Pacientes con diagnóstico de psicosis inducida por drogas, dentro de los 7 días previos a la v1 (o durante el estudio).
[22] Las pacientes que estén embarazadas, sean lactantes o deseen quedarse embarazadas (incluidos 30 días trasel estudio).
[23] Antecedentes de uno o más episodios convulsivos, excepto un único episodio de convulsiones febriles simples, entre 6 meses y 5 años. Se excluirá a los que presenten uno o más de los siguientes criterios:
• Familiares de primer grado con antecedentes de epilepsia idiopática.
• Presentar, desde 1 año previo al reclutamiento en el estudio, antecedentes de infección en el SNC, migraña no controlada, AIT o traumatismo craneal con pérdida de consciencia, o síndrome conmocional.
• Antedecentes de:
o Traumatismo craneal, ictus o infección del SNC, con déficit neurológico persistente.
o Neurocirugía.
o EEG con actividad paroxística
o Lesión estructural del cerebro, incluidas las anomalías congénitas
[24] Pacientes que hayan recibido TEC hasta 3 meses antes de v1, o en el estudio.
[25] Presentar diagnóstico de Parkinson, psicosis relacionada con demencia, o trastornos relacionados.
[26] Presentar hipertiroidismo o hipotiroidismo sin tratar.
[27] Presentar leucopenia o antecedentes sin etiología conocida o resuelta, o con antecedentes conocidos de agranulocitosis .
[28] Pacientes con el virus de la inmunodeficiencia humana (VIH+).
[29] Presentar 1) anticuerpos frente a la hepatitis C ó 2) antígenos de superficie de hepatitis B (HBsAg).
[30] Presentar en la v1 una concentración de ALT/SGPT o AST/SGOT > 2 veces el límite superior de lo normal, o una concentración de bilirrubina total > 1,5 veces el LSN del laboratorio.
[31] Presentar enfermedades agudas, graves o inestables, incluidos: diabetes controlada inadecuadamente, hipertrigliceridemia grave, accidentes cerebrovasculares, infecciones sistémicas agudas o enfermedades inmunológicas, trastornos cardiovasculares inestables , desnutrición, o enfermedades hepáticas, renales, digestivas, respiratorias, endocrinológicas, neurológicas o hematológicas.
[32] Presentar en la v1 una disfunción renal grave.
[33] Presentar en la v1 una concentración de prolactina > 200 ng/ml, si están recibiendo risperidona (excluidos si en la v1 la concentración de prolactina es > 300 ng/ml.
[34] Presentar en la v1 y en la v3 un intervalo QT corregido de acuerdo con la fórmula de Bazett (QTcB) > 450 ms (varones) o > 470 ms (mujeres).
[35] Ser incapaz de participar en el, o que no están dispuestos a colaborar durante su participación en el estudio.

E.5 End points

E.5.1

Primary end point(s)

El criterio principal de valoración de eficacia es el cambio respecto al valor basal en la puntuación total de la escala NSA-16. Las correspondientes comparaciones se realizarán en la visita 13, a un nivel de significación unilateral de 0,05. La puntuación total de la escala NSA-16 es la suma de 16 ítems específicos (cada ítem se puntúa de 1 a 6, y la puntuación total oscial entre 16 y 96). El cambio observado entre la visita basal y cada una de las visitas posbasales del período III del estudio se modelará mediante un modelo de efectos mixtos para medidas repetidas (MMRM), basado en la máxima verosimilitud restringida (REML)

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3

Other

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	51
F.4.2	For a multinational trial
F.4.2.1	In the EEA	102
F.4.2.2	In the whole clinical trial	380

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

2010-02-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-06-28

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