Treatment-Resistant Depression Cohort in Europe

Depressive Disorder, Treatment-Resistant Clinical Trial

Official title:

Treatment-Resistant Depression Cohort in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373253
• Other study ID #: CR108384
• Secondary ID: 54135419DEP4001
• Status: Completed
• Start date: February 13, 2018
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2022
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Locations

Country	Name	City	State
Belgium	Hauwaert An	Bilzen
Belgium	AZ Sint-Lucas	Brugge
Belgium	C.H.U. Brugmann	Bruxelles
Belgium	Psy Pluriel-Pastur	Bruxelles
Belgium	Psychiatrisch Centrum Dr Guislain	Gent
Belgium	Hôpital du Petit Bourgogne	Liege
Belgium	CHU Sart Tilman	Liège
Belgium	Clinique Saint Pierre	Ottignies
Belgium	St-Andries Ziekenhuis	Tielt
Germany	Klinik f. Psychiatrie, Psychosomatik u Psychoth	Bamberg
Germany	Alexander Schulze - Germany	Berlin
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Fliedner Klinik Berlin	Berlin
Germany	Praxis Dr. med. Jana Thomsen	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	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Medizinisches Versorgungszentrum Mittweida - Germany	Mittweida
Germany	NPZR - Neuropsychatrisches Zentrum Riem	Muenchen
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
Italy	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 Ospedaliero Universitaria San Martino	Genova
Italy	Azienda Sanitaria 3 Genovese	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	ASST Fatebenefratelli Sacco	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
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	Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza	Roma
Italy	Policlinico Universitario Agostino Gemelli	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
Netherlands	Praktijk voor Psychiatrie en Psychotherapie	Heerde
Netherlands	Psychiatriepraktijk Helmind	Helmond
Netherlands	MAPTA Psychiatrie	Zeist
Portugal	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	Évora
Portugal	Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa	Guilhufe - Penafiel
Portugal	Centro Hospitalar de Leiria	Leiria
Portugal	Fundação Champalimaud	Lisboa
Portugal	Hospital CUF Inf. Santo	Lisboa
Portugal	Hospital Magalhaes Lemos	Porto
Spain	Consulta Dr Salvador Sarro	Barcelona
Spain	Hosp. Clinic I Provincial de Barcelona	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hosp. Univ. de Bellvitge	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	Mostoles
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
United Kingdom	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	Barnes-jewish Hospital	London
United Kingdom	Institute of Psychiatry	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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Healthcare Resource Utilization in TRD Participants	Healthcare resources utilized in TRD participants will be estimated.	Up to 21 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Demographic Characteristics of TRD Participants	Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.	Baseline
Primary	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