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Treatment-Resistant Depression Cohort in Europe

Sponsor
Janssen-Cilag Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03373253
Collaborator
(none)
830
Enrollment
98
Locations
23.3
Actual Duration (Months)
8.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    830 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Treatment-Resistant Depression Cohort in Europe
    Actual Study Start Date :
    Feb 13, 2018
    Actual Primary Completion Date :
    Jan 24, 2020
    Actual Study Completion Date :
    Jan 24, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

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

    2. Treatment Patterns Over Time for TRD Participants [Baseline up to 21 months (end of study)]

      Treatment patterns (pharmacological and/or non-pharmacological) of TRD participants will be assessed over time.

    3. Percentage of Participants With Disease-Related Characteristics [Up to 21 months]

      Percentage of participants with disease-related characteristics for TRD among Major Depressive Disorder (MDD) participants will be assessed.

    4. Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) [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.

    5. Participant's Clinical Global Impression-Severity (CGI-S) Score [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.

    6. Participant's Clinical Global Impression-Change Scale (CGI-C) [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.

    7. Healthcare Resource Utilization in TRD Participants [Up to 21 months]

      Healthcare resources utilized in TRD participants will be estimated.

    8. European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire [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).

    9. Quality of Life in Depression Scale (QLDS) [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.

    10. Work Productivity and Activity Impairment (WPAI) [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.

    11. Level of Disability as Sheehan Disability Scale (SDS) [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.

    12. Sequence of Treatments in Participants with TRD [Up to 21 months]

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

    13. Demographic Characteristics of TRD Participants [Baseline]

      Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.

    14. Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Janssen-Cilag Ltd.

    Investigators

    • Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen-Cilag Ltd.
    ClinicalTrials.gov Identifier:
    NCT03373253
    Other Study ID Numbers:
    • CR108384
    • 54135419DEP4001
    First Posted:
    Dec 14, 2017
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Depressive Disorder
    Depressive Disorder, Treatment-Resistant

    Study Results

    No Results Posted as of Feb 3, 2022