Treatment-Resistant Depression Cohort in Europe

NCT03373253 | Completed

• 2 other identifiers: CR10838454135419DEP4001
• Study Type: observational
• Target: 830
• Locations: 7 countries
• Sites: 98

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.

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (14)

• Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics

  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

  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

  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)

  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

  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)

  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

  Healthcare resources utilized in TRD participants will be estimated.

  Up to 21 months

• European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire

  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)

  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)

  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)

  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

  Treatment sequences for participants with TRD within routine clinical care in Europe will be assessed.

  Up to 21 months

• Demographic Characteristics of TRD Participants

  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

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (98)

Hauwaert An

Bilzen, 3746, Belgium

Location

AZ Sint-Lucas

Bruges, 8310, Belgium

Location

C.H.U. Brugmann

Brussels, 1020, Belgium

Location

Psy Pluriel-Pastur

Brussels, 1180, Belgium

Location

Psychiatrisch Centrum Dr Guislain

Ghent, 9000, Belgium

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

Hôpital du Petit Bourgogne

Liège, 4000, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

St-Andries Ziekenhuis

Tielt, 8700, Belgium

Location

Klinik f. Psychiatrie, Psychosomatik u Psychoth

Bamberg, 96049, Germany

Location

Fliedner Klinik Berlin

Berlin, 10117, Germany

Location

Praxis Dr. med. Jana Thomsen

Berlin, 10245, Germany

Location

Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Alexander Schulze - Germany

Berlin, 13156, Germany

Location

Praxis Dr. med. Kirsten Hahn

Berlin, 13187, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09131, Germany

Location

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, 01307, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Klinikum der Johann Wolfgang Goethe -Universitaet

Frankfurt, 60528, Germany

Location

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

Gelsenkirchen, 45879, Germany

Location

Asklepios Klinik Nord - Ochsenzoll

Hamburg, 22419, Germany

Location

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

Liebenburg, 38704, Germany

Location

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, 39120, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Medizinisches Versorgungszentrum Mittweida - Germany

Mittweida, 09648, Germany

Location

NPZR - Neuropsychatrisches Zentrum Riem

München, 81829, Germany

Location

Johanniter Krankenhaus Oberhausen

Oberhausen, 46145, Germany

Location

Praxis Kuehn

Oranienburg, 16515, Germany

Location

Danuvius Klinik GmbH Pfaffenhofen

Pfaffenhofen, 85276, Germany

Location

Somni Bene GmbH

Schwerin, 19053, Germany

Location

Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

Siegen, 57076, Germany

Location

Praxis Dipl.-med. Stefan Kusserow

Stralsund, 18439, Germany

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

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

Brescia, 25100, Italy

Location

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, 95123, Italy

Location

Policlinico Universitario Germaneto

Catanzaro, 88100, Italy

Location

Azienda Sanitaria 3 Genovese

Genova, 16125, Italy

Location

Azienda Ospedaliero Universitaria San Martino

Genova, 16132, Italy

Location

Casa di Cura Villa Von Siebenthal

Genzano di Roma, 100045, Italy

Location

AUSL LE di Lecce

Lecce, 73100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, 98124, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

Monza, 20052, Italy

Location

Azienda Ospedaliera Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

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

Roma, 00189, Italy

Location

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

Rome, 00161, Italy

Location

Dipartimento Interaziendale di Salute Mentale

Siena, 53100, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette Di Ancona, 60126, Italy

Location

Praktijk voor Psychiatrie en Psychotherapie

Heerde, 8181HG, Netherlands

Location

Psychiatriepraktijk Helmind

Helmond, 5703 CE, Netherlands

Location

MAPTA Psychiatrie

Zeist, 3703 CB, Netherlands

Location

Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro

Aveiro, 3814-501, Portugal

Location

Unidade Local de Saúde do Baixo Alentejo, EPE

Beja, 7801-849, Portugal

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, 3000-075, Portugal

Location

Hospital do Espirito Santo, EPE

Evora, 7000-811, Portugal

Location

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

Guilhufe - Penafiel, 4564-007, Portugal

Location

Centro Hospitalar de Leiria

Leiria, 2410 197, Portugal

Location

Hospital CUF Inf. Santo

Lisbon, 135017, Portugal

Location

Fund. Champalimaud

Lisbon, 1400 038, Portugal

Location

Uls Santo Antonio - Hosp. Magalhaes Lemos

Porto, 4149-003, Portugal

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. de Bellvitge

Barcelona, 08907, Spain

Location

Consulta Dr Salvador Sarro

Barcelona, 8036, Spain

Location

Hosp. Gral. de Ciudad Real

Ciudad Real, 13005, Spain

Location

Centro de Salud Mental Toscar

Elche, 03205, Spain

Location

Hosp. Univ. de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Csm Fuencarral

Madrid, 28035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Puerta Del Sur

Móstoles, 28938, Spain

Location

Centro Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Hospital Psiquiátrico Provincial Rebullón

Pontevedra, 36415, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp. Univ. de Torrevieja

Torrevieja, 3186, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hosp. de Zafra

Zafra, 6300, Spain

Location

Royal Cornhill Hospital

Aberdeen, AB25 2ZH, United Kingdom

Location

University of Bristol

Bristol, BS8 2BN, United Kingdom

Location

Surrey and Borders Partnership NHS Foundation Trust

Chertsey, KT16 0AE, United Kingdom

Location

West Park Hospital

Darlington, DL2 2TS, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

Royal Edinburgh Hospital

Edinburgh, EH10 5HF, United Kingdom

Location

Burntwood and Lichfield CMHT

Lichfield, WS13 6EF, United Kingdom

Location

Institute of Psychiatry

London, SE5 8AF, United Kingdom

Location

Barnes-jewish Hospital

London, SW14 8SU, United Kingdom

Location

Berrywood Hospital

Northampton, NN5 6UD, United Kingdom

Location

Kingfisher Court

Radlett, WD7 9FB, United Kingdom

Location

Royal South Hants Hospital

Southampton, SO14 0YG, United Kingdom

Location

Cornwall Learning Disabilities Service

Truro, TR4 9LD, United Kingdom

Location

Westhaven Hospital

Weymouth, DT4 0QE, United Kingdom

Location

Vale House

Winsford, CW7 2AS, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 39435126 DERIVED

• 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.

  PMID: 38025433 DERIVED

• 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.

  PMID: 38025416 DERIVED

• 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.

  PMID: 34803777 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: February 13, 2018
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

PT (10); GB (15); ES (16); BE (9); IT (22); DE (23); NL (3)