Clinical Trials Register

Summary
EudraCT Number:	2013-004276-35
Sponsor's Protocol Code Number:	PI-0290-2012
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:	2014-06-09
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

2013-004276-35

A.3

Full title of the trial

Phase II, Double-blind, randomized, 1-way cross-over, to investigate the effectiveness of the combination of ascorbic acid (vitamin C) and tocopherol (vitamin E) versus placebo for the treatment of depressive disorders in elderly

Ensayo clínico fase II, doble ciego, aleatorizado, de una vía cruzada, para investigar la efectividad de la combinación de Ácido Ascórbico (vitamina C) y Tocoferol (vitamina E) versus placebo para el tratamiento de los trastornos depresivos en mayores

A.3.1

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

Clinical Trial, Phase II, randomized, double-blind, placebo-controlled, 1-way over with 2 treatment periods of 40 weeks duration.
Applicants: Research Group CTS546. IBIMA. Regional University Hospital. Málaga.
Subjects: Patients above 55 years with depressive disorders.

Diseño: Ensayo clínico, en fase II, aleatorizado, doble ciego controlado con placebo, cruzado de una vía, con 2 periodos de tratamiento de 40 semanas de duración.
Grupo solicitante: Grupo de investigación INTRAM CTS546. Fundación IMABIS. Hospital Carlos Haya. Málaga.
Sujetos: Pacientes mayores de 55 años con trastornos depresivos.

A.4.1

Sponsor's protocol code number

PI-0290-2012

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	Hospital Regional Universitario. IBIMA
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	Consejeria de Salud. Junta de Andalucia.
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	Hospital Regional Universitario. IBIMA
B.5.2	Functional name of contact point	Yolanda de Diego
B.5.3	Address:
B.5.3.1	Street Address	Hosp Civil Pab-6 sot. Plaza Hospital Civil
B.5.3.2	Town/ city	Malaga
B.5.3.3	Post code	29009
B.5.3.4	Country	Spain
B.5.4	Telephone number	34951290346
B.5.5	Fax number	34951290302
B.5.6	E-mail	ydediego@yahoo.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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	ORPHA60946
D.3 Description of the IMP
D.3.1	Product name	ascorbic acid
D.3.4	Pharmaceutical form	Capsule
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	ASCORBIC ACID
D.3.9.2	Current sponsor code	acido ascorbico
D.3.9.3	Other descriptive name	vitamin C
D.3.9.4	EV Substance Code	SUB05579MIG
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	400
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	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	alpha tocopherol
D.3.4	Pharmaceutical form	Capsule
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	alpha tocopherol
D.3.9.2	Current sponsor code	tocoferol
D.3.9.3	Other descriptive name	ALPHATOCOPHEROL ACETATE
D.3.9.4	EV Substance Code	SUB16136MIG
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)	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: 3
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	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	colloidal silica
D.3.4	Pharmaceutical form	Capsule
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	colloidal Silica
D.3.9.2	Current sponsor code	silice coloidal
D.3.9.3	Other descriptive name	COLLOIDAL SILICA
D.3.9.4	EV Substance Code	SUB21161
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	200 to 400
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
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

The trial aims to treat depression. The incidence of major depression in the elderly accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is studied. Besides depression in the elderly presents with cognitive impairment, impaired physical and social functioning, and predisposes to suicide. These are patients who often have multiple conditions and be taking numerous psychopharmacological treatments which hinders further treatment.

El ensayo pretende tratar la depresión. La incidencia de depresión mayor en el anciano supone entre un 3,6 y un 4,8% y aumenta hasta un 8-37,4% sí hablamos de trastornos depresivos en general. Además la depresión en el anciano cursa con deterioro cognitivo, deterioro del funcionamiento físico y social, y predispone al suicidio. Son pacientes que suelen presentar pluripatología y estar tomando numerosos tratamientos psicofarmacológicos lo que dificulta aún más su tratamiento.

E.1.1.1

Medical condition in easily understood language

The trial aims to treat depression. The incidence of major depression in the elderly accounts for between 3.6 and 4.8% and increases to 8 to 37.4% when depressive disorders in general is studied.

El ensayo pretende tratar la depresión. La incidencia de depresión mayor en el anciano supone entre un 3,6 y un 4,8% y aumenta hasta un 8-37,4% sí hablamos de trastornos

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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10012378
E.1.2	Term	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

Primary outcomes measurements: the improvement in neuropsychiatric symptoms through instruments BDI -IA ; GADS , GAD- 7; GHQ28 ; CGI and MEC- 30 at 0, 3 and 6 months during the trial.

Resultados primarios mediciones: la mejora de los síntomas neuropsiquiátricos a través de instrumentos BDI-IA; Gads, GAD-7; GHQ28; CGI y MEC-30 a 0, 3 y 6 meses durante el juicio.

E.2.2

Secondary objectives of the trial

Secondary Outcome Measures: Levels of blood oxidative stress

Las medidas de resultado secundarias: niveles de estrés oxidativo en sangre

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria:
• Diagnosis of mild depression smaller or larger by Mini International Neuropsychiatric Interview (MINI).
• Having more than 55 years old
• Have signed the informed consent document before you start participating in the trial.

Criterios de inclusión:
• Diagnóstico de depresión menor o mayor leve mediante Mini International Neuropsychiatric Interview (MINI).
• Tener una edad mayor de 55 años
• Haber firmado el documento de consentimiento informado, antes de iniciar su participación en el ensayo.

E.4

Principal exclusion criteria

Exclusion criteria:
• Individuals with other psychiatric diagnosis as the first diagnosis.
• To have suffered serious medical problems in the last 12 months.
• Are taking more than 100mg of vitamin E or C a day in the last 4 months.
• Having physical, mental or sensory problems that prevent the assessment of effectiveness.
• Hypersensitivity to any component of the preparation.
• Previous pathology of kidney stones

Criterios de exclusión:
• Se excluirán del estudio los individuos con otro diagnostico psiquiátrico como primer diagnóstico.
• Haber padecido problemas médicos serios en los últimos 12 meses.
• Estar tomando más de 100mg de vitaminas E o C al día en los últimos 4 meses.
• Tener problemas físicos, psíquicos o sensoriales que impidan la evaluación de la efectividad.
• Hipersensibilidad a alguno de los componentes del preparado.
• Antecedentes de patología de cálculos renales

E.5 End points

E.5.1

Primary end point(s)

12 weeks of treatment or serious adverse events

12 semanas de tratamiento o efectos adversos serios.

E.5.1.1

Timepoint(s) of evaluation of this end point

T0 = initial or baseline assessment,
T1: 2nd assessment after 12 weeks of treatment,

T0= valoración inicial o basal,
T1: 2ª valoración tras 12 semanas de tratamiento,

E.5.2

Secondary end point(s)

serious adverse events

efectos adversos serios.

E.5.2.1

Timepoint(s) of evaluation of this end point

T2: 3rd assessment after 24 weeks of treatment

T2: 3ª valoración tras 24 semanas de tratamiento

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

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)

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

cruzado de una via

one-way cross over

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.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

last visit of the patient after 24 weeks of treatment or serious adverse events

ultima visita de ultimo paciente tras 24 semanas de tratamiento o por efectos adversos severos

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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)

A visit of follow up 3 months after finishing the treatment will be offered to each participant

Una visita de seguimiento a los 3 meses de tratamiento se ofrecera a cada participante

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

2014-10-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-12

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

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