Clinical Trials Register

Summary
EudraCT Number:	2011-005878-37
Sponsor's Protocol Code Number:	039(C)SC11063
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-12
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005878-37

A.3

Full title of the trial

A randomized, double-blind study comparing the efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of patients with Major Depressive Disorder

Studio randomizzato, doppio cieco per valutare l'efficacia e la sicurezza di trazodone OAD in confronto a venlafaxina XR nel trattamento di pazienti con Disturbo Depressivo Maggiore

A.3.1

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

Efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of Major Depressive Disorder

Efficacia e sicurezza di trazodone OAD e venlafaxina XR nel trattamento del disturbo depressivo maggiore

A.3.2

Name or abbreviated title of the trial where available

trazodone OAD in MDD

trazodone OAD nel disturbo depressivo maggiore

A.4.1

Sponsor's protocol code number

039(C)SC11063

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	ANGELINI
B.1.3.4	Country	Italy
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	ANGELINI ACRAF SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ANGELINI ACRAF SpA
B.5.2	Functional name of contact point	Clinical Trial Application Unit
B.5.3	Address:
B.5.3.1	Street Address	P.le della Stazione snc
B.5.3.2	Town/ city	S.Palomba Pomezia (Roma)
B.5.3.3	Post code	00040
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 06-91045335
B.5.5	Fax number	+39 06-9194333
B.5.6	E-mail	g.orticelli@angelini.it

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	Trazodone HCl containing Contramid® prolonged release tablets
D.3.2	Product code	039(C)
D.3.4	Pharmaceutical form	Prolonged-release 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	TRAZODONE HYDROCHLORIDE
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	039
D.3.9.4	EV Substance Code	SUB15596MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
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)	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	EFEXOR*28CPS 75MG R.P.
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Prolonged-release 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	VENLAFAXINE HYDROCHLORIDE
D.3.9.1	CAS number	99300-78-4
D.3.9.4	EV Substance Code	SUB05087MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	84.85
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

Major Depressive Disorder

Disturbo Depressivo Maggiore

E.1.1.1

Medical condition in easily understood language

Depression

Depressione

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLGT
E.1.2	Classification code	10012375
E.1.2	Term	Depressed mood disorders and disturbances
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10037175
E.1.2	Term	Psychiatric disorders
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLT
E.1.2	Classification code	10012401
E.1.2	Term	Depressive disorders
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 evaluate the efficacy and safety of trazodone OAD vs venlafaxine XR after an 8-week treatment period in patients with major depressive disorder.

Valutare l'efficacia e la sicurezza di trazodone OAD verso venlafaxina XR dopo un periodo di trattamento di 8 settimane in pazienti con disturbo depressivo maggiore

E.2.2

Secondary objectives of the trial

not applicable

non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Men and women outpatients >=18 years of age;major depressive disorder according to DSM-IV criteria;HAMD17 score >=18 at both screening and baseline visits;symptoms of depression for at least one month;legally capable to give their written informed consent;women of childbearing potential must agree not to start a pregnancy from the signature of the informed consent

Pazienti ambulatoriali maschi e femmine >=18 anni; disturbo depressivo maggiore secondo i criteri del DSM-IV;punteggio della scala HAMD-17 >=18 allo screening ed al basale; sintomi di depressione da almeno un mese; legalmente in grado di fornire il proprio consenso scritto; volontà di non iniziare una gravidanza dalla firma del consenso informato (donne potenzialmente fertili)

E.4

Principal exclusion criteria

use of venlafaxine or trazodone within the previous six months; clinically significant hepatic or renal diseases; myocardial infarction (within 6 months); positive present history of glaucoma; history of risk factors for Torsade de Pointes; clinically abnormal electrolytes values; concomitant treatment with drugs known for QT prolongation; QTcF values higher than 450 msec;resistant major depression; seizure events, alcohol or psychoactive substance abuse or addiction; acute risk of suicide (HAMD, criterion 3 with a value > 3); presence of any primary psychiatric disorder other than major depression; pregnancy, lactation; use of antipsychotic drugs; any anxiolytic or sedative hypnotic drug; any drugs with psychotropic effects; concomitant treatment with CYP3A4 inhibitors; hyperthyroidism, clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests; vulnerable subjects

uso di venlafaxina o trazodone negli ultimi 6 mesi; malattie epatiche o renali clinicamente significative; infarto del miocardio (entro 6 mesi); presenza di glaucoma; rischio di Torsione di Punta; alterazioni clinicamente significative degli elettroliti, trattamento con farmaci che inducono il prolungamento del QT; valori di QTcF > 450 msec; depressione maggiore resistente; attacchi epilettici; abuso o dipendenza da alcol e da sostanze psicoattive; rischio di suicidio (HAMD, criterio 3 con un valore > 3); presenza di disturbi psichiatrici diversi dalla depressione maggiore; donne in gravidanza e allattamento; uso di sostanze antipsicotiche, ansiolitiche o sedative-ipnotiche; uso di farmaci con effetto psicotropico; trattamento con inibitori CYP3A4; ipertiroidismo; alterazioni clinicamente significative all’esame fisico, ai segni vitali, all’ECG ed ai test di laboratorio; soggetti vulnerabili.

E.5 End points

E.5.1

Primary end point(s)

mean change from baseline in HAMD score at the final Visit.

cambiamento medio del punteggio della scala HAMD alla visita finale rispetto al basale.

E.5.1.1

Timepoint(s) of evaluation of this end point

at day 56 of treatment (final visit)

al giorno 56 di trattamento (visita finale)

E.5.2

Secondary end point(s)

mean change from baseline in MADRS score at the final visit; CGI-Severity of illness and CGI-Global improvement at the final visit; rate of responders defined as patients with a 50% decrease with respect to baseline on the HAMD score at the final visit; rate of patients with remission (HAMD score <=7) at the final visit

cambiamento medio del punteggio della scala MADRS alla visita finale rispetto al basale; CGI-severità della malattia e CGI-miglioramento globale alla visita finale; percentuale di responder definita come pazienti con una diminuzione del 50% del punteggio della scala HAMD alla visita finale rispetto al basale;percentuale di pazienti con remissione (HAMD <=7) alla visita finale

E.5.2.1

Timepoint(s) of evaluation of this end point

at day 56 of treatment (final visit)

al giorno 56 di trattamento (visita finale)

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

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)

Yes

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)

Yes

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

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

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

LVLS

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

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

300

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

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

360

F.4.2.2

In the whole clinical trial

360

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)

Responders at the final visit may continue the same medication taken during the trial. An unblinded third party dispenser will open the treatment code and will prescribe the formulation available on the market. No responders at the final visit will have their study medication tapered from 1 to 3 weeks, according to the maximum dose reached during the study

I responders alla visita finale possono continuare lo stesso farmaco assunto durante lo studio. Un medico terzo aprirà il codice di trattamento e prescriverà la formulazione disponibile sul mercato. I non responders alla visita finale ridurranno in 1-3 settimane la dose di farmaco in base alla dose massima raggiunta durante lo studio.

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

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-04

P. End of Trial
P.	End of Trial Status	Completed

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