A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

NCT ID: NCT04338321

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 676 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-21
• Study Completion Date: 2022-07-15

Brief Summary

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Detailed Description

A depressive state with classical symptoms such as low (depressive/sad) mood, markedly diminished interest in activities, significant weight loss/gain, insomnia or hypersomnia, psychomotor agitation/retardation, excessive fatigue, inappropriate guilt, diminished concentration, and recurrent thoughts of death, persisting for more than 2 weeks is classified as major depressive disorder (MDD). The mechanism of action of ketamine is distinct from conventional antidepressants (ADs), which target the monoamines (serotonin, norepinephrine, and/or dopamine). Esketamine, the S-enantiomer of ketamine, is approved and widely used for the induction and maintenance of anesthesia via intramuscular or intravenous (IV) administration. There is a significant unmet need to develop novel AD treatments based on the relevant psychophysiological pathways underlying MDD. The goal of any novel treatment would be the rapid and long-lasting relief of depressive symptoms, especially in participants with treatment-resistant depression (TRD), who lack a sufficient response to the currently available treatment strategies. The study consists of a Screening Phase (up to 14 days), an Acute Phase (8 Weeks), a Maintenance Phase (24 Weeks) and a Safety Follow-up Phase (2 Weeks). Safety assessment includes adverse event, serious adverse events, physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, suicidal risk monitoring. The total duration of the study is approximately 36 Weeks for all participants.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esketamine Arm

Participants will receive treatment with esketamine nasal spray (28 milligram \[mg\] \[initial dose for elderly participants 65 to 74 years of age and adults of Japanese ancestry; may be used throughout the study in these populations; may be uptitrated in 28 mg increments\], 56 mg \[initial dose for adult participants aged 18 to 64 years and may be used for all age groups throughout the study\], or 84 mg \[maximum dose esketamine nasal spray may be uptitrated to\]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI).

Group Type: EXPERIMENTAL

Esketamine 28 mg

Intervention Type: DRUG

Esketamine will be self-administered at a dose of 28 mg as nasal spray.

Esketamine 56 mg

Intervention Type: DRUG

Esketamine will be self-administered at a dose of 56 mg as nasal spray.

Esketamine 84 mg

Intervention Type: DRUG

Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.

SSRI/SNRI

Intervention Type: DRUG

Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).

Comparator Arm

Participants will continue to take their current SSRI/SNRI augmented with quetiapine extended release (XR) as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable). In adult participants aged 18 to 64 years, the initial dose is 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 \[lowest effective dose\]; a further dose increase to 300 mg/day on Day 5 and onward will be based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose is 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day will be based on individual participant evaluation no earlier than Day 22.

Group Type: ACTIVE_COMPARATOR

Quetiapine XR 50 mg

Intervention Type: DRUG

Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

Quetiapine XR 100 mg

Intervention Type: DRUG

Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

Quetiapine XR 150 mg

Intervention Type: DRUG

Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

SSRI/SNRI

Intervention Type: DRUG

Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).

Interventions

Esketamine 28 mg

Esketamine will be self-administered at a dose of 28 mg as nasal spray.

Intervention Type: DRUG

Esketamine 56 mg

Esketamine will be self-administered at a dose of 56 mg as nasal spray.

Intervention Type: DRUG

Esketamine 84 mg

Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.

Intervention Type: DRUG

Quetiapine XR 50 mg

Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

Intervention Type: DRUG

Quetiapine XR 100 mg

Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

Intervention Type: DRUG

Quetiapine XR 150 mg

Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.

Intervention Type: DRUG

SSRI/SNRI

Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI)
• At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (>=) 34
• The current antidepressive treatment, was immediately preceded by nonresponse to at least 1 but not more than 5 different, consecutive treatments (all within the current moderate to severe antidepressive episode) with anti-depressants (ADs) taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented
• Must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor [SSRI/SNRI])
• Must be on a single oral SSRI/SNRI on Day 1 prior to randomization

Exclusion Criteria

• Received treatment with esketamine or ketamine in the current moderate to severe depressive episode
• Received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 milligram per day (mg/day)
• Had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT
• Has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview
• Received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
• has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the Mini International Neuropsychiatric Interview [MINI]), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, or antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
• age at onset of first episode of MDD was more than or equal to (>=) 55 years
• has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator'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) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trials

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, , Argentina

FunDaMos

Buenos Aires, , Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, , Argentina

Fundacion Lennox

Córdoba, , Argentina

Instituto Medico DAMIC

Córdoba, , Argentina

Sanatorio Prof Leon S Morra S A

Córdoba, , Argentina

Instituto de Neurociencias San Agustin

La Plata, , Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, , Argentina

Medical University Graz

Graz, , Austria

Schmitz and Schmitz

Vienna, , Austria

Medical University Vienna MUV

Vienna, , Austria

Anima

Alken, , Belgium

Pz Duffel

Duffel, , Belgium

Clinique Psychiatrique des Frères Alexiens

Henri-Chapelle, , Belgium

Sint-Franciskusziekenhuis

Heusden-Zolder, , Belgium

ARIADNE

Lede, , Belgium

CHU de Liege

Liège, , Belgium

CPN - Centro de Pesquisa em Neurociências Ltda

Belo Horizonte, , Brazil

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, , Brazil

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, , Brazil

C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)

São Paulo, , Brazil

BR Trials

São Paulo, , Brazil

State Psychiatric Hospital Kardzhali

Kardzhali, , Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

Mental Health Center - Plovdiv

Plovdiv, , Bulgaria

Mental Health Center - Rousse

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, , Bulgaria

MHC - Sofia, EOOD

Sofia, , Bulgaria

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

Sofia, , Bulgaria

Psychiatricka ambulance Saint Anne s.r.o.

Brno, , Czechia

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, , Czechia

NeuropsychiatrieHK, s.r.o.

Hradec Kralove-Vekose, , Czechia

A Shine S R O

Pilsen, , Czechia

Clintrial s r o

Prague, , Czechia

AD71 s.r.o.

Prague, , Czechia

Medical Services Prague S R O

Prague, , Czechia

Institut Neuropsychiatricke pece

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Psykiatrien i Region Syddanmark

Esbjerg N, , Denmark

Mederon LTD at ARTES

Helsinki, , Finland

Psykiatrinen Palvelukeskus Solvum Oy

Helsinki, , Finland

Savon Psykiatripalvelu

Kuopio, , Finland

Universitaetsklinikum der RWTH Aachen

Aachen, , Germany

Rheinhessen Fachklinik Alzey

Alzey, , Germany

Emovis GmbH

Berlin, , Germany

Charite Campus Benjamin Franklin

Berlin, , Germany

Medizinisches Versorgungszentrum LiO GmbH

Berlin, , Germany

Alexander Schulze - Germany

Berlin, , Germany

Praxis Dr. med. Kirsten Hahn

Berlin, , Germany

Vivantes Klinikum Spandau

Berlin, , Germany

Universitatsklinikum Bonn

Bonn, , Germany

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, , Germany

Klinikum Dortmund gGmbH

Dortmund, , Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, , Germany

Universitatsklinikum Frankfurt

Frankfurt am Main, , Germany

Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik

Freiburg im Breisgau, , Germany

SRH Waldklinikum Gera GmbH

Gera, , Germany

Georg August Universitat Universitatsmedizin Gottingen

Göttingen, , Germany

Evangelisches Krankenhaus Bethanien gGmbH

Greifswald, , Germany

Universitaetsklinik Hamburg-Eppendorf

Hamburg, , Germany

Klinische Forschung Hamburg

Hamburg, , Germany

Klinische Forschung Hannover-Mitte GmbH

Hanover, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universität Heidelberg

Heidelberg, , Germany

Oberhavel Kliniken GmbH

Hennigsdorf, , Germany

Universitätsklinikum des Saarlandes

Homburg, , Germany

Universitatsklinikum Jena

Jena, , Germany

Panakeia - Arzneimittelforschung GmbH

Leipzig, , Germany

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, , Germany

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, , Germany

Pharmakologisches Studienzentrum Chemnitz GmbH

Mittweida, , Germany

Universitatsklinikum Munster

Münster, , Germany

Ruppiner Kliniken

Neuruppin, , Germany

Praxis Prof. Steinwachs

Nuremberg, , Germany

Johanniter Krankenhaus Oberhausen

Oberhausen, , Germany

Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik

Pfaffenhofen, , Germany

Somni Bene GmbH

Schwerin, , Germany

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany

Stralsund, , Germany

Aiginition Hospital of Athens

Athens, , Greece

'Dafni' Psychiatric Hospital of Attica

Athens, , Greece

Venizeleio General Hospital

Crete, , Greece

Psychiatric Clinic 'Agios Charalampos'

Heraklion, , Greece

University General Hospital of Ioannina

Ioannina, , Greece

University General Hospital of Rio Patras

Pátrai, , Greece

424 Military Hospital of Thessaloniki

Thessaloniki, , Greece

Psychiatric Hospital of Thessaloniki

Thessaloniki, , Greece

G Papanikolaou Hospital of Thessaloniki

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

Budapest, , Hungary

Processus Kft

Budapest, , Hungary

Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház

Debrecen, , Hungary

Bugat Pal Korhaz

Gyöngyös, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

Kalocsa, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Rambam Medical Center

Haifa, , Israel

Shalvata Mental Health Center

Hod HaSharon, , Israel

Beer Yaakov Mental Health Center

Lod, , Israel

Geha Mental Health Center

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Telaviv, , Israel

Republican Scientific and Practical Center of Mental Health

Almaty, , Kazakhstan

Medical Center for Psychological Healt SME

Nur-Sultan, , Kazakhstan

East-Kazakhstan Regional Centre of Mental Health

Ust-Kamenogorsk, , Kazakhstan

Hospital Raja Permaisuri Bainun

Ipoh, , Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital Pengajar Universiti Putra Malaysia

Serdang, , Malaysia

Hospital Tuanku Jaafar

Seremban, , Malaysia

Brain Research Center

Amsterdam, , Netherlands

AMC

Amsterdam, , Netherlands

LUMC

Leiden, , Netherlands

Haukeland University Hospital

Hordaland, , Norway

Sykehuset Ostfold

Moss, , Norway

St Olav University Hospital

Trondheim, , Norway

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, , Poland

Osrodek Badan Klinicznych CLINSANTE S C

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Centrum Badan Klinicznych PI House sp z o o

Gdansk, , Poland

Centrum Medyczne Care Clinic Katowice

Katowice, , Poland

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, , Poland

Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego

Lodz, , Poland

SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych

Lodz, , Poland

Centrum Medyczne Luxmed Sp z o o

Lublin, , Poland

Osrodek Badan Klinicznych CLINSANTE S C

Torun, , Poland

Hospital de Braga

Braga, , Portugal

Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa

Guilhufe - Penafiel, , Portugal

Hosp. Cuf Tejo

Lisbon, , Portugal

Fund. Champalimaud

Lisbon, , Portugal

Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Lisbon, , Portugal

Uls Loures Odivelas - Hosp. Loures

Loures, , Portugal

Cape Town Clinical Research Centre

Cape Town, , South Africa

Flexivest 14 Research

Cape Town, , South Africa

Gert Bosch Pretoria South Africa

Garsfontein, , South Africa

Chonnam National University Hospital

Gwangju, , South Korea

Wonkwang University Hospital

Iksan, , South Korea

KyungHee University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Psykiatriska kliniken

Gothenburg, , Sweden

Affecta Pskyiatrimottagning

Halmstad, , Sweden

Psykiatriska kliniken

Luleå, , Sweden

ProbarE i Lund AB

Lund, , Sweden

ONE LIFETIME Lakarmottagning

Skövde, , Sweden

ProbarE i Stockholm AB

Stockholm, , Sweden

Changhua Christian Hospital

Changhua, , Taiwan

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Kai-Syuan Psychiatric Hospital

Kaohsiung City, , Taiwan

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Medical University

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Bakirkoy Mental Health Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Erenkoy Mental Health Hospital

Istanbul, , Turkey (Türkiye)

Uskudar University Neuropsychiatry Hospital

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Selcuk University Medical Faculty

Konya, , Turkey (Türkiye)

Liv Hospital

Samsun, , Turkey (Türkiye)

Namik Kemal University

Tekirdağ, , Turkey (Türkiye)

American Center for Psychiatry and Neurology

Abu Dhabi, , United Arab Emirates

Countries

Argentina; Austria; Belgium; Brazil; Bulgaria; Czechia; Denmark; Finland; Germany; Greece; Hungary; Israel; Kazakhstan; Malaysia; Netherlands; Norway; Poland; Portugal; South Africa; South Korea; Sweden; Taiwan; Turkey (Türkiye); United Arab Emirates

References

Lan CH, Wei JC. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93-94. doi: 10.1056/NEJMc2313230. No abstract available.

Reference Type: DERIVED

PMID: 38169503 (View on PubMed)

Horowitz MA, Ploderl M, Naudet F. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93. doi: 10.1056/NEJMc2313230. No abstract available.

Reference Type: DERIVED

PMID: 38169502 (View on PubMed)

Reif A, Bitter I, Buyze J, Cebulla K, Frey R, Fu DJ, Ito T, Kambarov Y, Llorca PM, Oliveira-Maia AJ, Messer T, Mulhern-Haughey S, Rive B, von Holt C, Young AH, Godinov Y; ESCAPE-TRD Investigators. Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. N Engl J Med. 2023 Oct 5;389(14):1298-1309. doi: 10.1056/NEJMoa2304145.

Reference Type: DERIVED

PMID: 37792613 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002992-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

54135419TRD3013

Identifier Type: OTHER

Identifier Source: secondary_id

CR108787

Identifier Type: -

Identifier Source: org_study_id