Treatment-Resistant Depression Cohort in Europe

April 25, 2025 updated by: Janssen-Cilag Ltd.
The purpose of this study is to assess the participants socio-demographics and disease-related characteristics, long-term naturalistic treatment patterns and the clinical, social and economic outcomes of routine clinical practice in the treatment of participants with treatment-resistant depression (TRD) in a variety of European countries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This TRD cohort study will collect critically important data from routine clinical practice in Europe which will further substantiate the understanding of TRD in European clinical practice, with the aim of improving guidance and informing the development of better treatment strategies for this medically important condition. All data recorded in the case report form (CRF) should be documented in participants' medical records, that will be the primary data source of each participant. Participants who meet the diagnostic criteria for Major Depressive Disorder (MDD) and the diagnostic criteria for TRD, and are initiating or planned to initiate a new antidepressive treatment regimen will participate in the study. The end of the entire study will be 6 months after enrollment of the last participant in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
830

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bilzen, Belgium, 3746
        • Hauwaert An
      • Brugge, Belgium, 8310
        • AZ Sint-Lucas
      • Bruxelles, Belgium, 1020
        • C.H.U. Brugmann
      • Bruxelles, Belgium, 1180
        • Psy Pluriel-Pastur
      • Gent, Belgium, 9000
        • Psychiatrisch Centrum Dr Guislain
      • Liege, Belgium, 4000
        • Hôpital du Petit Bourgogne
      • Liège, Belgium, 4000
        • Chu Sart Tilman
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
      • Tielt, Belgium, 8700
        • St-Andries Ziekenhuis
  • Germany
      • Bamberg, Germany, 96049
        • Klinik f. Psychiatrie, Psychosomatik u Psychoth
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Berlin, Germany, 13187
        • Praxis Dr. med. Kirsten Hahn
      • Berlin, Germany, 13156
        • Alexander Schulze - Germany
      • Berlin, Germany, 10117
        • Fliedner Klinik Berlin
      • Berlin, Germany, 10245
        • Praxis Dr. med. Jana Thomsen
      • Chemnitz, Germany, 09131
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carcus Dresden
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Frankfurt, Germany, 60528
        • Klinikum der Johann Wolfgang Goethe -Universitaet
      • Gelsenkirchen, Germany, 45879
        • Gemeinschaftspraxis F. Neurologie, Psychiatrie Und Psychotherapie Dres. Leonhardt U. Sallach
      • Hamburg, Germany, 22419
        • Asklepios Klinik Nord - Ochsenzoll
      • Liebenburg, Germany, 38704
        • Privat-Nervenklinik, Dr. med. Kurt Fontheim - Germany
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg A.oe.R
      • Mainz, Germany, 55131
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Mittweida, Germany, 09648
        • Medizinisches Versorgungszentrum Mittweida - Germany
      • Muenchen, Germany, 81829
        • NPZR - Neuropsychatrisches Zentrum Riem
      • Oberhausen, Germany, 46145
        • Johanniter Krankenhaus Oberhausen
      • Oranienburg, Germany, 16515
        • Praxis Kuehn
      • Pfaffenhofen, Germany, 85276
        • Danuvius Klinik GmbH Pfaffenhofen
      • Schwerin, Germany, 19053
        • Somni Bene GmbH
      • Siegen, Germany, 57076
        • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
      • Stralsund, Germany, 18439
        • Praxis Dipl.-med. Stefan Kusserow
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Brescia, Italy, 25100
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
      • Catania, Italy, 95123
        • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
      • Catanzaro, Italy, 88100
        • Policlinico Universitario Germaneto
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Genova, Italy, 16125
        • Azienda Sanitaria 3 Genovese
      • Genzano di Roma, Italy, 100045
        • Casa di Cura Villa Von Siebenthal
      • Lecce, Italy, 73100
        • AUSL LE di Lecce
      • Messina, Italy, 98124
        • Azienda Ospedaliera Universitaria Policlinico G. Martino
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20157
        • ASST Fatebenefratelli Sacco
      • Monza, Italy, 20052
        • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
      • Novara, Italy, 28100
        • Azienda Ospedaliera Universitaria Maggiore della Carità
      • Parma, Italy, 43100
        • Azienda Ospedaliero Universitaria di Parma
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00189
        • Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
      • Rome, Italy, 00161
        • Umberto I Pol. di Roma-Università di Roma La Sapienza
      • Siena, Italy, 53100
        • Dipartimento Interaziendale di Salute Mentale
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Torrette Di Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Netherlands
      • Heerde, Netherlands, 8181HG
        • Praktijk voor Psychiatrie en Psychotherapie
      • Helmond, Netherlands, 5703 CE
        • Psychiatriepraktijk Helmind
      • Zeist, Netherlands, 3703 CB
        • MAPTA Psychiatrie
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro
      • Beja, Portugal, 7801-849
        • Unidade Local de Saúde do Baixo Alentejo, EPE
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra, EPE
      • Guilhufe - Penafiel, Portugal, 4564-007
        • Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
      • Leiria, Portugal, 2410 197
        • Centro Hospitalar de Leiria
      • Lisboa, Portugal, 135017
        • Hospital CUF Inf. Santo
      • Lisboa, Portugal, 1400 038
        • Fund. Champalimaud
      • Porto, Portugal, 4149-003
        • Uls Santo Antonio - Hosp. Magalhaes Lemos
      • Évora, Portugal, 7000-811
        • Hospital do Espirito Santo, EPE
  • Spain
      • Barcelona, Spain, 08003
        • Hosp. Del Mar
      • Barcelona, Spain, 08907
        • Hosp. Univ. de Bellvitge
      • Barcelona, Spain, 8036
        • Consulta Dr Salvador Sarro
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Ciudad Real, Spain, 13005
        • Hosp. Gral. de Ciudad Real
      • Elche, Spain, 03205
        • Centro de Salud Mental Toscar
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hosp. Univ. de Gran Canaria Dr. Negrin
      • Madrid, Spain, 28035
        • Csm Fuencarral
      • Madrid, Spain, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Mostoles, Spain, 28938
        • Hosp. Puerta Del Sur
      • Oviedo, Spain, 33011
        • Centro Salud Mental La Corredoria
      • Pontevedra, Spain, 36415
        • Hospital Psiquiátrico Provincial Rebullón
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Torrevieja, Spain, 3186
        • Hosp. Univ. de Torrevieja
      • Valencia, Spain, 46026
        • Hosp. Univ. I Politecni La Fe
      • Zafra, Spain, 6300
        • Hosp. de Zafra
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZH
        • Royal Cornhill Hospital
      • Bristol, United Kingdom, BS8 2BN
        • University of Bristol
      • Chertsey, United Kingdom, KT16 0AE
        • Surrey and Borders Partnership NHS Foundation Trust
      • Darlington, United Kingdom, DL2 2TS
        • West Park Hospital
      • Derby, United Kingdom, DE22 3DT
        • Royal Derby Hospital
      • Edinburgh, United Kingdom, EH10 5HF
        • Royal Edinburgh Hospital
      • Lichfield, United Kingdom, WS13 6EF
        • Burntwood and Lichfield CMHT
      • London, United Kingdom, SE5 8AF
        • Institute of Psychiatry
      • London, United Kingdom, SW14 8SU
        • Barnes-Jewish Hospital
      • Northampton, United Kingdom, NN5 6UD
        • Berrywood Hospital
      • Radlett, United Kingdom, WD7 9FB
        • Kingfisher Court
      • Southampton, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Truro, United Kingdom, TR4 9LD
        • Cornwall Learning Disabilities Service
      • Weymouth, United Kingdom, DT4 0QE
        • Westhaven Hospital
      • Winsford, United Kingdom, CW7 2AS
        • Vale House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with Major Depressive Disorder (MDD) who fulfill the most commonly adopted criteria for treatment-resistant depression (TRD) with outcomes in routine clinical practice across the European region will be part of the study.

Description

Inclusion Criteria:

  • Meets the diagnostic criteria for single episode or recurrent MDD, without psychotic features, according to either the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • Is considered to suffer from a moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 20 at baseline
  • Meets/has met the TRD criteria, defined as lack of clinically meaningful improvement, as indicated by a Clinical Global Impression-Change (CGI-C) score >= 4 and/or less than or equal to (<=) 25 percent (%) improvement in MADRS total score (lack of tolerability is not an indicator of non-response), with at least 2 different oral antidepressant treatments (of the same class, of a different class, or a combination of antidepressants or antidepressant with adjunctive antipsychotics) in the current episode of depression, prescribed in adequate dosages (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [MGH ATRQ]) for adequate duration (at least 6 weeks) with adequate treatment adherence assessed by physicians
  • Is initiating a new antidepressive treatment to treat the current depressive episode
  • Must be capable of providing informed consent, based on the opinion of the participating physician

Exclusion Criteria:

  • Has a current or prior diagnosis of a psychotic disorder, MDD with psychotic features, bipolar or related disorders, or intellectual disability, according to DSM-5 or ICD-10
  • Has homicidal ideation/intent or has suicidal ideation with some intent to act, within 1 month prior to enrollment (per the physician's clinical judgment or based on the Columbia-Suicide Severity Rating Scale [C-SSRS] corresponding to a response of "Yes" on Item 4 [active suicidal ideation with some intent to act, without specific plan] or Item 5 [active suicidal ideation with specific plan and intent]) or a history of suicidal behavior within 1 year prior to enrollment
  • Has a history of moderate or severe substance use disorder or severe alcohol use disorder according to DSM 5 criteria, except for nicotine and caffeine, within 6 months prior to enrollment
  • Has a lifetime history of hallucinogen-related substance use disorder, with ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3,4 methylenedioxy-methamphetamine (MDMA)
  • Has participated in or is currently enrolled in any clinical trial or observational study within the current episode
  • Has previously received esketamine at any time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants With Diagnosis of Depression
This study will evaluate participant's socio-demographic, disease-related and treatment-related characteristics along with outcomes in routine clinical practice across the European region. Only data available within clinical practice, through routine therapeutic procedures and diagnostic assessments, will be recorded. Individual participant information will be recorded from participant's medical records or by use of specific questionnaires.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics
Time Frame: Baseline up to 21 months (end of study)
Number of TRD participants with change from baseline in socio-demographic characteristics (education, occupational status, living status, economic status, marital status, legal status) will be assessed.
Baseline up to 21 months (end of study)
Treatment Patterns Over Time for TRD Participants
Time Frame: Baseline up to 21 months (end of study)
Treatment patterns (pharmacological and/or non-pharmacological) of TRD participants will be assessed over time.
Baseline up to 21 months (end of study)
Percentage of Participants With Disease-Related Characteristics
Time Frame: Up to 21 months
Percentage of participants with disease-related characteristics for TRD among Major Depressive Disorder (MDD) participants will be assessed.
Up to 21 months
Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Up to 21 months
The MADRS is a clinician-rated scale designed to measure changes in depression severity due to antidepressant treatment.The MADRS consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms) for a total possible score of 60. Higher scores represent a more severe condition.
Up to 21 months
Participant's Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Up to 21 months
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Up to 21 months
Participant's Clinical Global Impression-Change Scale (CGI-C)
Time Frame: Up to 21 months
The CGI-C is a clinician-rated 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). The CGI C scale will be used in this study to assess any improvement or worsening in a participant's condition versus previous assessments.
Up to 21 months
Healthcare Resource Utilization in TRD Participants
Time Frame: Up to 21 months
Healthcare resources utilized in TRD participants will be estimated.
Up to 21 months
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire
Time Frame: Up to 21 months
The EQ-5D-5L descriptive system comprises 5 dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression - each of which is divided into 5 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating slight problems, Level 3 indicating moderate problems, Level 4 indicating severe problems, and Level 5 indicating extreme problems).
Up to 21 months
Quality of Life in Depression Scale (QLDS)
Time Frame: Up to 21 months
The QLDS is a disease-specific PRO used to document the impact that depression has on a participant's quality of life. The QLDS is a 34-item self-rated questionnaire consisting of dichotomous response questions, with responses being either True/Not True or Yes/No. It is scored binomially (that is, 0 or 1), with high scores on the QLDS indicating a lower quality of life.
Up to 21 months
Work Productivity and Activity Impairment (WPAI)
Time Frame: Up to 21 months
The WPAI produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Up to 21 months
Level of Disability as Sheehan Disability Scale (SDS)
Time Frame: Up to 21 months
Participant-reported outcome of functional impact and associated disability will be documented by use of the SDS, a 5-item questionnaire. The first 3 items of the SDS document disruption of work/school, social life, and family life/home responsibilities, each using a rating from 0 to 10. The scores for the first 3 items are summed to create a total score of between 0 and 30, a higher score indicative of greater impairment. It also has 1 item on days lost from school or work and 1 item on days when underproductive.
Up to 21 months
Sequence of Treatments in Participants with TRD
Time Frame: Up to 21 months
Treatment sequences for participants with TRD within routine clinical care in Europe will be assessed.
Up to 21 months
Demographic Characteristics of TRD Participants
Time Frame: Baseline
Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Baseline
Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Baseline
Suicidal ideation or behavior will be measured using C-SSRS score. C-SSRS is a clinician rated assessment of suicidal behavior and/ or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108384
  • 54135419DEP4001 (Other Identifier: Janssen-Cilag Ltd.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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