Depressive Disorder, Treatment-ResistantNCT03373253
Treatment-Resistant Depression Cohort in Europe
An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen-Cilag Ltd. at 98 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- How many people
- 830 participants
- Where
- 98 sitesin 7 countries
- Study dates
- 13 Feb 2018to 24 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
98 sites in 7 countries.
98 sites in 7 countries
Germany23 sites
Klinik f. Psychiatrie, Psychosomatik u Psychoth
Bamberg, 96049
Fliedner Klinik Berlin
Berlin, 10117
Praxis Dr. med. Jana Thomsen
Berlin, 10245
Charite Campus Benjamin Franklin
Berlin, 12203
Alexander Schulze - Germany
Berlin, 13156
Praxis Dr. med. Kirsten Hahn
Berlin, 13187
Klinikum Chemnitz gGmbH
Chemnitz, 09131
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, 01307
Kliniken Essen-Mitte
Essen, 45136
Klinikum der Johann Wolfgang Goethe -Universitaet
Frankfurt, 60528
Gemeinschaftspraxis F. Neurologie, Psychiatrie Und Psychotherapie Dres. Leonhardt U. Sallach
Gelsenkirchen, 45879
Asklepios Klinik Nord - Ochsenzoll
Hamburg, 22419
Privat-Nervenklinik, Dr. med. Kurt Fontheim - Germany
Liebenburg, 38704
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, 39120
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
Medizinisches Versorgungszentrum Mittweida - Germany
Mittweida, 09648
NPZR - Neuropsychatrisches Zentrum Riem
München, 81829
Johanniter Krankenhaus Oberhausen
Oberhausen, 46145
Praxis Kuehn
Oranienburg, 16515
Danuvius Klinik GmbH Pfaffenhofen
Pfaffenhofen, 85276
Somni Bene GmbH
Schwerin, 19053
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen, 57076
Praxis Dipl.-med. Stefan Kusserow
Stralsund, 18439
Italy22 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25100
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, 95123
Policlinico Universitario Germaneto
Catanzaro, 88100
Azienda Sanitaria 3 Genovese
Genova, 16125
Azienda Ospedaliero Universitaria San Martino
Genova, 16132
Casa di Cura Villa Von Siebenthal
Genzano di Roma, 100045
AUSL LE di Lecce
Lecce, 73100
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98124
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
ASST Fatebenefratelli Sacco
Milan, 20157
Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
Monza, 20052
Azienda Ospedaliera Universitaria Maggiore della Carità
Novara, 28100
Azienda Ospedaliero Universitaria di Parma
Parma, 43100
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda ospedaliera Sant'Andrea di Roma- Università di Roma La Sapienza
Roma, 00189
Umberto I Pol. di Roma-Università di Roma La Sapienza
Rome, 00161
Dipartimento Interaziendale di Salute Mentale
Siena, 53100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, 60126
Spain16 sites
Hosp. Del Mar
Barcelona, 08003
Hosp Clinic de Barcelona
Barcelona, 08036
Hosp. Univ. de Bellvitge
Barcelona, 08907
Consulta Dr Salvador Sarro
Barcelona, 8036
Hosp. Gral. de Ciudad Real
Ciudad Real, 13005
Centro de Salud Mental Toscar
Elche, 03205
Hosp. Univ. de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
Csm Fuencarral
Madrid, 28035
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Hosp. Puerta Del Sur
Móstoles, 28938
Centro Salud Mental La Corredoria
Oviedo, 33011
Hospital Psiquiátrico Provincial Rebullón
Pontevedra, 36415
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Hosp. Univ. de Torrevieja
Torrevieja, 3186
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Hosp. de Zafra
Zafra, 6300
United Kingdom15 sites
Royal Cornhill Hospital
Aberdeen, AB25 2ZH
University of Bristol
Bristol, BS8 2BN
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 0AE
West Park Hospital
Darlington, DL2 2TS
Royal Derby Hospital
Derby, DE22 3DT
Royal Edinburgh Hospital
Edinburgh, EH10 5HF
Burntwood and Lichfield CMHT
Lichfield, WS13 6EF
Institute of Psychiatry
London, SE5 8AF
Barnes-jewish Hospital
London, SW14 8SU
Berrywood Hospital
Northampton, NN5 6UD
Kingfisher Court
Radlett, WD7 9FB
Royal South Hants Hospital
Southampton, SO14 0YG
Cornwall Learning Disabilities Service
Truro, TR4 9LD
Westhaven Hospital
Weymouth, DT4 0QE
Vale House
Winsford, CW7 2AS
Portugal10 sites
Centro Hospitalar do Baixo Vouga E P E Unidade de Aveiro
Aveiro, 3814-501
Unidade Local de Saúde do Baixo Alentejo, EPE
Beja, 7801-849
Hospital de Braga
Braga, 4710-243
Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075
Hospital do Espirito Santo, EPE
Evora, 7000-811
Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
Guilhufe - Penafiel, 4564-007
Centro Hospitalar de Leiria
Leiria, 2410 197
Hospital CUF Inf. Santo
Lisbon, 135017
Fund. Champalimaud
Lisbon, 1400 038
Uls Santo Antonio - Hosp. Magalhaes Lemos
Porto, 4149-003
Belgium9 sites
Hauwaert An
Bilzen, 3746
AZ Sint-Lucas
Bruges, 8310
C.H.U. Brugmann
Brussels, 1020
Psy Pluriel-Pastur
Brussels, 1180
Psychiatrisch Centrum Dr Guislain
Ghent, 9000
CHU Sart Tilman
Liège, 4000
Hôpital du Petit Bourgogne
Liège, 4000
Clinique Saint Pierre
Ottignies, 1340
St-Andries Ziekenhuis
Tielt, 8700
Netherlands3 sites
Praktijk voor Psychiatrie en Psychotherapie
Heerde, 8181HG
Psychiatriepraktijk Helmind
Helmond, 5703 CE
MAPTA Psychiatrie
Zeist, 3703 CB
About this study
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.
Read the 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.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 months
Healthcare Resource Utilization in TRD Participants
Healthcare resources utilized in TRD participants will be estimated.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 months
Demographic Characteristics of TRD Participants
Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start13 Feb 2018
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373253
- Sponsor's protocol ID
- CR108384
- Other IDs
- 54135419DEP4001
- Status last verified
- Apr 2025
- First submitted
- 8 Dec 2017
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
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.
PubMed 39435126Oliveira-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.
PubMed 38025433Oliveira-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.
PubMed 38025416Perugi 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.
PubMed 34803777
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment-Resistant Depression Cohort in Europe
- ClinicalTrials.gov ID
- NCT03373253
- Acronym / sponsor ID
- CR108384
- Conditions
- Depressive Disorder, Treatment-Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics
Time frame: 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.
Treatment Patterns Over Time for TRD Participants
Time frame: Baseline up to 21 months (end of study)
Treatment patterns (pharmacological and/or non-pharmacological) of TRD participants will be assessed over time.
Percentage of Participants With Disease-Related Characteristics
Time frame: Up to 21 months
Percentage of participants with disease-related characteristics for TRD among Major Depressive Disorder (MDD) participants will be assessed.
Severity of Symptoms as Measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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.
Participant's Clinical Global Impression-Severity (CGI-S) Score
Time frame: 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.
Participant's Clinical Global Impression-Change Scale (CGI-C)
Time frame: 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.
Healthcare Resource Utilization in TRD Participants
Time frame: Up to 21 months
Healthcare resources utilized in TRD participants will be estimated.
European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire
Time frame: 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).
Quality of Life in Depression Scale (QLDS)
Time frame: 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.
Work Productivity and Activity Impairment (WPAI)
Time frame: 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.
Level of Disability as Sheehan Disability Scale (SDS)
Time frame: 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.
Sequence of Treatments in Participants with TRD
Time frame: Up to 21 months
Treatment sequences for participants with TRD within routine clinical care in Europe will be assessed.
Demographic Characteristics of TRD Participants
Time frame: Baseline
Demographic characteristics (such as age and gender) of TRD participants will be assessed at baseline.
Suicidality Risk (Ideation and Attempts) as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 39435126Oliveira-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.
- Derived from this study: PubMed 38025433Oliveira-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.
- Derived from this study: PubMed 38025416Oliveira-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.
- Derived from this study: PubMed 34803777Perugi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
98 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Treatment-Resistant, run by Janssen-Cilag Ltd. at 98 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in Germany, Italy, Spain, United Kingdom, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Resistant Depression (TRD) Participants With Change From Baseline in Socio-demographic Characteristics (time frame: Baseline up to 21 months (end of study)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373253, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.