Clinical trial NCT03373253: Treatment-Resistant Depression Cohort in Europe
Official title: Treatment-Resistant Depression Cohort in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Treatment-Resistant
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics
timeFrame: Baseline up to 21 months (end of study)
measure: Treatment Patterns Over Time for TRD Participants
timeFrame: Baseline up to 21 months (end of study)
measure: Percentage of Participants With Disease-Related Characteristics
timeFrame: Up to 21 months
measure: Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Up to 21 months
measure: Participant's Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Up to 21 months
measure: Participant's Clinical Global Impression-Change Scale (CGI-C)
timeFrame: Up to 21 months
measure: Healthcare Resource Utilization in TRD Participants
timeFrame: Up to 21 months
measure: European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire
timeFrame: Up to 21 months
measure: Quality of Life in Depression Scale (QLDS)
timeFrame: Up to 21 months
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Up to 21 months
measure: Level of Disability as Sheehan Disability Scale (SDS)
timeFrame: Up to 21 months
measure: Sequence of Treatments in Participants with TRD
timeFrame: Up to 21 months
measure: Demographic Characteristics of TRD Participants
timeFrame: Baseline
measure: Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bilzen
country: Belgium
facility: Hauwaert An
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Bruxelles
country: Belgium
facility: C.H.U. Brugmann
city: Bruxelles
country: Belgium
facility: Psy Pluriel-Pastur
city: Gent
country: Belgium
facility: Psychiatrisch Centrum Dr Guislain
city: Liege
country: Belgium
facility: Hôpital du Petit Bourgogne
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Tielt
country: Belgium
facility: St-Andries Ziekenhuis
city: Bamberg
country: Germany
facility: Klinik f. Psychiatrie, Psychosomatik u Psychoth
city: Berlin
country: Germany
facility: Fliedner Klinik Berlin
city: Berlin
country: Germany
facility: Praxis Dr. med. Jana Thomsen
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Alexander Schulze - Germany
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carcus Dresden
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe -Universitaet
city: Gelsenkirchen
country: Germany
facility: Gemeinschaftspraxis F. Neurologie, Psychiatrie Und Psychotherapie Dres. Leonhardt U. Sallach
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord - Ochsenzoll
city: Liebenburg
country: Germany
facility: Privat-Nervenklinik, Dr. med. Kurt Fontheim - Germany
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Mittweida
country: Germany
facility: Medizinisches Versorgungszentrum Mittweida - Germany
city: Muenchen
country: Germany
facility: NPZR - Neuropsychatrisches Zentrum Riem
city: Oberhausen
country: Germany
facility: Johanniter Krankenhaus Oberhausen
city: Oranienburg
country: Germany
facility: Praxis Kuehn
city: Pfaffenhofen
country: Germany
facility: Danuvius Klinik GmbH Pfaffenhofen
city: Schwerin
country: Germany
facility: Somni Bene GmbH
city: Siegen
country: Germany
facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
city: Stralsund
country: Germany
facility: Praxis Dipl.-med. Stefan Kusserow
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
city: Catania
country: Italy
facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
city: Catanzaro
country: Italy
facility: Policlinico Universitario Germaneto
city: Genova
country: Italy
facility: Azienda Sanitaria 3 Genovese
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Genzano di Roma
country: Italy
facility: Casa di Cura Villa Von Siebenthal
city: Lecce
country: Italy
facility: AUSL LE di Lecce
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
city: Rome
country: Italy
facility: Umberto I Pol. di Roma-Università di Roma La Sapienza
city: Siena
country: Italy
facility: Dipartimento Interaziendale di Salute Mentale
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Torrette Di Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
city: Heerde
country: Netherlands
facility: Praktijk voor Psychiatrie en Psychotherapie
city: Helmond
country: Netherlands
facility: Psychiatriepraktijk Helmind
city: Zeist
country: Netherlands
facility: MAPTA Psychiatrie
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro
city: Beja
country: Portugal
facility: Unidade Local de Saúde do Baixo Alentejo, EPE
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE
city: Guilhufe - Penafiel
country: Portugal
facility: Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria
city: Lisboa
country: Portugal
facility: Hospital CUF Inf. Santo
city: Lisboa
country: Portugal
facility: Fund. Champalimaud
city: Porto
country: Portugal
facility: Uls Santo Antonio - Hosp. Magalhaes Lemos
city: Évora
country: Portugal
facility: Hospital do Espirito Santo, EPE
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp. Univ. de Bellvitge
city: Barcelona
country: Spain
facility: Consulta Dr Salvador Sarro
city: Ciudad Real
country: Spain
facility: Hosp. Gral. de Ciudad Real
city: Elche
country: Spain
facility: Centro de Salud Mental Toscar
city: Las Palmas de Gran Canaria
country: Spain
facility: Hosp. Univ. de Gran Canaria Dr. Negrin
city: Madrid
country: Spain
facility: Csm Fuencarral
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Mostoles
country: Spain
facility: Hosp. Puerta Del Sur
city: Oviedo
country: Spain
facility: Centro Salud Mental La Corredoria
city: Pontevedra
country: Spain
facility: Hospital Psiquiátrico Provincial Rebullón
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Torrevieja
country: Spain
facility: Hosp. Univ. de Torrevieja
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Zafra
country: Spain
facility: Hosp. de Zafra
city: Aberdeen
country: United Kingdom
facility: Royal Cornhill Hospital
city: Bristol
country: United Kingdom
facility: University of Bristol
city: Chertsey
country: United Kingdom
facility: Surrey and Borders Partnership NHS Foundation Trust
city: Darlington
country: United Kingdom
facility: West Park Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Edinburgh Hospital
city: Lichfield
country: United Kingdom
facility: Burntwood and Lichfield CMHT
city: London
country: United Kingdom
facility: Institute of Psychiatry
city: London
country: United Kingdom
facility: Barnes-jewish Hospital
city: Northampton
country: United Kingdom
facility: Berrywood Hospital
city: Radlett
country: United Kingdom
facility: Kingfisher Court
city: Southampton
country: United Kingdom
facility: Royal South Hants Hospital
city: Truro
country: United Kingdom
facility: Cornwall Learning Disabilities Service
city: Weymouth
country: United Kingdom
facility: Westhaven Hospital
city: Winsford
country: United Kingdom
facility: Vale House
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.