Treatment-Resistant Depression Cohort in Europe

NCT ID: NCT03373253

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 830 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2020-01-24

Brief Summary

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.

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.

Conditions

Depressive Disorder, Treatment-Resistant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

Hauwaert An

Bilzen, , Belgium

AZ Sint-Lucas

Bruges, , Belgium

C.H.U. Brugmann

Brussels, , Belgium

Psy Pluriel-Pastur

Brussels, , Belgium

Psychiatrisch Centrum Dr Guislain

Ghent, , Belgium

CHU Sart Tilman

Liège, , Belgium

Hôpital du Petit Bourgogne

Liège, , Belgium

Clinique Saint Pierre

Ottignies, , Belgium

St-Andries Ziekenhuis

Tielt, , Belgium

Klinik f. Psychiatrie, Psychosomatik u Psychoth

Bamberg, , Germany

Fliedner Klinik Berlin

Berlin, , Germany

Praxis Dr. med. Jana Thomsen

Berlin, , Germany

Charite Campus Benjamin Franklin

Berlin, , Germany

Alexander Schulze - Germany

Berlin, , Germany

Praxis Dr. med. Kirsten Hahn

Berlin, , Germany

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, , Germany

Kliniken Essen-Mitte

Essen, , Germany

Klinikum der Johann Wolfgang Goethe -Universitaet

Frankfurt, , Germany

Gemeinschaftspraxis F. Neurologie, Psychiatrie Und Psychotherapie Dres. Leonhardt U. Sallach

Gelsenkirchen, , Germany

Asklepios Klinik Nord - Ochsenzoll

Hamburg, , Germany

Privat-Nervenklinik, Dr. med. Kurt Fontheim - Germany

Liebenburg, , Germany

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, , Germany

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, , Germany

Medizinisches Versorgungszentrum Mittweida - Germany

Mittweida, , Germany

NPZR - Neuropsychatrisches Zentrum Riem

München, , Germany

Johanniter Krankenhaus Oberhausen

Oberhausen, , Germany

Praxis Kuehn

Oranienburg, , Germany

Danuvius Klinik GmbH Pfaffenhofen

Pfaffenhofen, , Germany

Somni Bene GmbH

Schwerin, , Germany

Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

Siegen, , Germany

Praxis Dipl.-med. Stefan Kusserow

Stralsund, , Germany

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

Brescia, , Italy

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, , Italy

Policlinico Universitario Germaneto

Catanzaro, , Italy

Azienda Sanitaria 3 Genovese

Genova, , Italy

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Casa di Cura Villa Von Siebenthal

Genzano di Roma, , Italy

AUSL LE di Lecce

Lecce, , Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

ASST Fatebenefratelli Sacco

Milan, , Italy

Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

Monza, , Italy

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, , Italy

Azienda Ospedaliero Universitaria di Parma

Parma, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza

Roma, , Italy

Umberto I Pol. di Roma-Università di Roma La Sapienza

Rome, , Italy

Dipartimento Interaziendale di Salute Mentale

Siena, , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette Di Ancona, , Italy

Praktijk voor Psychiatrie en Psychotherapie

Heerde, , Netherlands

Psychiatriepraktijk Helmind

Helmond, , Netherlands

MAPTA Psychiatrie

Zeist, , Netherlands

Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro

Aveiro, , Portugal

Unidade Local de Saúde do Baixo Alentejo, EPE

Beja, , Portugal

Hospital de Braga

Braga, , Portugal

Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, , Portugal

Hospital do Espirito Santo, EPE

Evora, , Portugal

Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa

Guilhufe - Penafiel, , Portugal

Centro Hospitalar de Leiria

Leiria, , Portugal

Hospital CUF Inf. Santo

Lisbon, , Portugal

Fund. Champalimaud

Lisbon, , Portugal

Uls Santo Antonio - Hosp. Magalhaes Lemos

Porto, , Portugal

Hosp. Del Mar

Barcelona, , Spain

Hosp Clinic de Barcelona

Barcelona, , Spain

Hosp. Univ. de Bellvitge

Barcelona, , Spain

Consulta Dr Salvador Sarro

Barcelona, , Spain

Hosp. Gral. de Ciudad Real

Ciudad Real, , Spain

Centro de Salud Mental Toscar

Elche, , Spain

Hosp. Univ. de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

Csm Fuencarral

Madrid, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp. Puerta Del Sur

Móstoles, , Spain

Centro Salud Mental La Corredoria

Oviedo, , Spain

Hospital Psiquiátrico Provincial Rebullón

Pontevedra, , Spain

Corporacio Sanitari Parc Tauli

Sabadell, , Spain

Hosp. Univ. de Torrevieja

Torrevieja, , Spain

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Hosp. de Zafra

Zafra, , Spain

Royal Cornhill Hospital

Aberdeen, , United Kingdom

University of Bristol

Bristol, , United Kingdom

Surrey and Borders Partnership NHS Foundation Trust

Chertsey, , United Kingdom

West Park Hospital

Darlington, , United Kingdom

Royal Derby Hospital

Derby, , United Kingdom

Royal Edinburgh Hospital

Edinburgh, , United Kingdom

Burntwood and Lichfield CMHT

Lichfield, , United Kingdom

Institute of Psychiatry

London, , United Kingdom

Barnes-jewish Hospital

London, , United Kingdom

Berrywood Hospital

Northampton, , United Kingdom

Kingfisher Court

Radlett, , United Kingdom

Royal South Hants Hospital

Southampton, , United Kingdom

Cornwall Learning Disabilities Service

Truro, , United Kingdom

Westhaven Hospital

Weymouth, , United Kingdom

Vale House

Winsford, , United Kingdom

Countries

Belgium; Germany; Italy; Netherlands; Portugal; Spain; United Kingdom

References

Oliveira-Maia AJ, Rive B, Godinov Y, Mulhern-Haughey S. Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: results from the ICEBERG study. Front Psychiatry. 2024 Oct 7;15:1459633. doi: 10.3389/fpsyt.2024.1459633. eCollection 2024.

Reference Type: DERIVED

PMID: 39435126 (View on PubMed)

Oliveira-Maia AJ, Morrens J, Rive B, Godinov Y, Cabrieto J, Perualila N, Barbreau S, Mulhern-Haughey S. ICEBERG study: an indirect adjusted comparison estimating the long-term benefit of esketamine nasal spray when compared with routine treatment of treatment resistant depression in general psychiatry. Front Psychiatry. 2023 Oct 31;14:1250980. doi: 10.3389/fpsyt.2023.1250980. eCollection 2023.

Reference Type: DERIVED

PMID: 38025433 (View on PubMed)

Oliveira-Maia AJ, Rive B, Morrens J, Godinov Y, Cabrieto J, Perualila N, Mulhern-Haughey S. Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression: results from the ICEBERG study. Front Psychiatry. 2023 Oct 31;14:1250987. doi: 10.3389/fpsyt.2023.1250987. eCollection 2023.

Reference Type: DERIVED

PMID: 38025416 (View on PubMed)

Perugi G, Calo P, De Filippis S, Rosso G, Vita A, Adami M, Ascione G, Morrens J, Delmonte D. Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study. Front Psychiatry. 2021 Nov 5;12:769693. doi: 10.3389/fpsyt.2021.769693. eCollection 2021.

Reference Type: DERIVED

PMID: 34803777 (View on PubMed)

Other Identifiers

54135419DEP4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108384

Identifier Type: -

Identifier Source: org_study_id