Clinical Trials Register

Summary
EudraCT Number:	2019-001325-27
Sponsor's Protocol Code Number:	18314A
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:	2019-12-02
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

2019-001325-27

A.3

Full title of the trial

Interventional, open-label effectiveness study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder comorbid with generalized anxiety disorder

Estudio intervencionista y sin enmascaramiento sobre la eficacia de dosis flexibles de vortioxetina en los síntomas depresivos en pacientes con depresión mayor acompañada de trastorno de ansiedad

A.3.1

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

Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)

Vortioxetina en pacientes con depresión acompañada de trastorno de ansiedad generalizado (TAG)

A.4.1

Sponsor's protocol code number

18314A

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	H. Lundbeck A/S
B.1.3.4	Country	Denmark
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	H. Lundbeck A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	H. Lundbeck A/S
B.5.2	Functional name of contact point	LundbeckClinicalTrials@lundbeck.com
B.5.3	Address:
B.5.3.1	Street Address	Ottiliavej 9
B.5.3.2	Town/ city	Valby
B.5.3.3	Post code	2500
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004536301311
B.5.5	Fax number	004536301940
B.5.6	E-mail	LundbeckClinicalTrials@lundbeck.com

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	Brintellix 10 mg Film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.4	EV Substance Code	SUB88928
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)	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	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	Brintellix 20 mg Film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	H. Lundbeck A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	VORTIOXETINE
D.3.9.1	CAS number	508233-74-7
D.3.9.4	EV Substance Code	SUB88928
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)	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

Depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD)

Síntomas depresivos en pacientes con depresión mayor (DM) acompañada de trastorno de ansiedad generalizado (TAG)

E.1.1.1

Medical condition in easily understood language

Depression and anxiety

Depresión y ansiedad

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10057840
E.1.2	Term	Major depression
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

To assess the effectiveness of 8-week acute treatment with 10–20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) comorbid with generalized anxiety disorder (GAD).

Evaluar la eficacia del tratamiento breve de 8 semanas con 10-20 mg/día de vortioxetina en los síntomas depresivos en pacientes con depresión mayor (DM) acompañada de trastorno de ansiedad generalizado (TAG)

E.2.2

Secondary objectives of the trial

To assess the effectiveness of vortioxetine on:
• anxiety symptoms
• functioning
• global clinical impression
• health-related quality of life

• Evaluar la eficacia de la vortioxetina en:
- síntomas de ansiedad;
- actividad;
- impresión clínica global;
- calidad de vida relacionada con la salud.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI)
• The patient has had the current MDE for <12 months
• The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
• The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit
• The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit

• Pacientes con diagnóstico principal de DM según el DSM 5®, confirmado mediante la entrevista breve neuropsiquiátrica internacional (MINI).
• Pacientes cuya DM actual lleve presente <12 meses
• Pacientes con trastorno de ansiedad generalizado (TAG) según el DSM-5®. Diagnóstico obtenido antes de la DM actual
• Puntuación total de la escala de evaluación de la depresión de Montgomery y Åsberg (MADRS) ≥22 en la visita inicial
• Pacientes con una puntuación ≥20 en la escala de evaluación de la ansiedad de Hamilton (HAM-A) en la visita inicial

E.4

Principal exclusion criteria

• The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
• The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator’s opinion.

• Pacientes con un trastorno psiquiátrico o trastorno del eje I (criterios del DSM-5®) actual confirmado como diagnóstico principal, que no sea la DM, evaluado mediante la entrevista breve neuropsiquiátrica internacional (MINI) u otra entrevista de diagnóstico
• Pacientes con antecedentes de episodios de depresión mayor considerados resistentes al tratamiento, definidos como una respuesta insuficiente (respuesta terapéutica incompleta o nula) a dos tratamientos anteriores con dosis aceptables de antidepresivos convencionales durante un mínimo de 6 semanas o pacientes con depresión resistente al tratamiento según el criterio del investigador

E.5 End points

E.5.1

Primary end point(s)

Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score

Cambio desde el inicio hasta la semana 8 en la puntuación total de la escala de evaluación de la depresión de Montgomery y Åsberg (MADRS)

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to Week 8

Desde la visita inicial hasta la semana 8

E.5.2

Secondary end point(s)

• Change in Hamilton Anxiety Rating Scale (HAM-A) total score*
• Change in Hospital Anxiety and Depression Scale (HADS) total score*
• Change in Functioning Assessment Short Test (FAST) total score*
• Change in Clinical Global Impression - Severity of Illness (CGI-S) score*
• Clinical Global Impression Scale- Global Improvement (CGI-I) score**
• Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score*

• Cambio en la puntuación total de la escala de evaluación de la ansiedad de Hamilton (HAM-A)*
• Cambio en la puntuación total de la escala de ansiedad y depresión hospitalaria (HADS)*
• Cambio en la puntuación total en la prueba breve de evaluación del funcionamiento (FAST)*
• Cambio en la puntuación de la impresión clínica global sobre la gravedad de la enfermedad (CGI-S)*
• Cambio en la puntuación de la impresión clínica global sobre la mejoría global (CGI-I)**
• Cambio en la puntuación total del cuestionario sobre calidad del disfrute de la vida y satisfacción (Q-LES-Q)*

E.5.2.1

Timepoint(s) of evaluation of this end point

*) From baseline to Week 8
**) At Week 8

*) Desde la visita inicial hasta la semana 8
**) En la semana 8

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

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

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.8.3

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

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

Estonia

Finland

France

Italy

Korea, Republic of

Spain

Switzerland

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

The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. The last protocol-specified contact is a safety follow-up. This may be a telephone contact, unless an SAE has occurred since the previous visit. The safety follow-up must be conducted 4 weeks after the last dose of IMP.

El final del estudio global se define como el último contacto especificado en el protocolo con el último paciente que quede en el estudio. El último contacto especificado en el protocolo es un seguimiento de la seguridad, que puede ser un contacto telefónico a menos que se haya producido un AAG desde la visita anterior. El seguimiento de la seguridad debe realizarse 4 semanas después de la última dosis del PEI.

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:

100

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

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

2019-12-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-03-09

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