Treatment-Resistant Depression Cohort in Europe

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: Completed
• Conditions: Depressive Disorder, Treatment-Resistant

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: Observational
• Enrollment (Actual): 830

Contacts and Locations

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
    • Universitätsmedizin der Johannes Gutenberg-Universität 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, 20157
    • ASST Fatebenefratelli Sacco
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Monza, Italy, 20052
    • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
  • Novara, Italy, 28100
    • Azienda Ospedaliera Universitaria Maggiore della Carita
  • 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 Universitario 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, 1400-038
    • Fundação Champalimaud
  • Lisboa, Portugal, 135017
    • Hospital CUF Inf. Santo
  • Porto, Portugal, 4149-003
    • Hospital Magalhaes Lemos
  • Évora, Portugal, 7000-811
    • Hospital do Espírito Santo, EPE
• Spain
  • Barcelona, Spain, 08036
    • Hosp. Clinic I Provincial de Barcelona
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Barcelona, Spain, 08907
    • Hosp. Univ. de Bellvitge
  • Barcelona, Spain, 8036
    • Consulta Dr Salvador Sarro
  • 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, 28040
    • Hosp. Univ. Fund. Jimenez Diaz
  • Madrid, Spain, 28035
    • Csm Fuencarral
  • 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

Eligibility Criteria

• Ages Eligible for Study: 16 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: CR108384; 54135419DEP4001 (Other Identifier: Janssen-Cilag Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No