Clinical trial NCT04829318: A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
Official title: Open-label Long-Term Extension Study for Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment From Study 54135419TRD3013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Treatment resistant depression
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).


Eligibility criteria: Inclusion Criteria:

* Completed the maintenance phase (Week 32) of Study 54135419TRD3013 (NCT04338321) and had esketamine nasal spray in combination with continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study 54135419TRD3013, and continues to be willing to be treated with esketamine nasal spray
* Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study
* Must be medically stable based on the investigator's judgment
* A woman of childbearing potential must have a negative urine pregnancy test on Day 1
* Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (that is, esketamine nasal spray), must fulfill the following criteria: must be practicing a highly effective method of contraception with his female partner, must use a condom if his partner is pregnant, and must agree not to donate sperm

Exclusion Criteria:

* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Completed Study 54135419TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
* Has developed during participation in Study 54135419TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: cerebrovascular disease following stroke or transient ischemic attack, aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), intracerebral hemorrhage, coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (example, coronary angioplasty or bypass graft surgery), uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability, hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (New York Heart Association \[NYHA\] Class III-IV) of any etiology
* Significant pulmonary insufficiency, including chronic obstructive pulmonary disease
* 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 Day 1, per the investigator's clinical judgment; or based on the Columbia-suicide severity rating scale (C-SSRS) performed at Week 32 visit of Study 54135419TRD3013, 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
* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention

Primary outcomes:
measure: Percentage of Participants with Intervention-emergent Adverse Events (AEs)
timeFrame: Up to Week 104
measure: Percentage of Participants with Intervention-emergent AEs of special interest (AESI)
timeFrame: Up to Week 104
measure: Suicidal Ideation and Behavior as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to Week 104
Secondary outcomes:
measure: Percentage of Participants with no Relapse Until the end of the Prospective Observation Period at Week 104
timeFrame: Week 104
measure: Change from Baseline in Study 54135419TRD3013 with Clinician-rated MADRS Scale Score
timeFrame: Baseline, up to Week 104
measure: Change from Baseline in Study 54135419TRD3013 with Clinical Global Impression -severity (CGI-S) Scale Score
timeFrame: Baseline, up to Week 104
measure: Change from Baseline in Study 54135419TRD3013 with Patient Health Questionnaire (PHQ) 9-item Total Score
timeFrame: Baseline, up to Week 104
measure: Change from Baseline in Study 54135419TRD3013 with European Quality of Life (EuroQol) Group, 5 Dimension, 5-Level (EQ-5D-5L) Questionnaire Score
timeFrame: Baseline, up to Week 104
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: FunDaMos
city: Cordoba
country: Argentina
facility: CEN Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Fundacion Lennox
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC
city: Cordoba
country: Argentina
facility: Sanatorio Prof Leon S Morra S A
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustin
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Alken
country: Belgium
facility: Anima
city: Rousse
country: Bulgaria
facility: Mental Health Center - Rousse
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
city: Sofia
country: Bulgaria
facility: Centre for Mental Health Prof.N.Shipkovenski EOOD
city: Brno
country: Czechia
facility: Psychiatricka ambulance Saint Anne s.r.o.
city: Brno
country: Czechia
facility: Psychiatricka ambulance, MUDr. Marta Holanova
city: Hradec Kralove
country: Czechia
facility: NeuropsychiatrieHK, s.r.o.
city: Plzen
country: Czechia
facility: A Shine S R O
city: Prague
country: Czechia
facility: Institut Neuropsychiatricke pece
city: Praha 10
country: Czechia
facility: AD71 s.r.o.
city: Praha 6
country: Czechia
facility: Medical Services Prague S R O
city: Helsinki
country: Finland
facility: Mederon LTD at ARTES
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum LiO GmbH
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH
city: Pfaffenhofen
country: Germany
facility: Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik
city: Schwerin
country: Germany
facility: Somni Bene GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Heraklion
country: Greece
facility: Psychiatric Clinic 'Agios Charalampos'
city: Patras
country: Greece
facility: University General Hospital of Rio Patras
city: Thessaloniki
country: Greece
facility: G Papanikolaou Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Processus Kft
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Serdang
country: Malaysia
facility: Hospital Pengajar Universiti Putra Malaysia
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Bialystok
country: Poland
facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Katowice
country: Poland
facility: Centrum Medyczne Care Clinic Katowice
city: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Lodz
country: Poland
facility: Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
city: Lodz
country: Poland
facility: SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
city: Torun
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C
city: Cape Town
country: South Africa
facility: Cape Town Clinical Research Centre
city: Pretoria
country: South Africa
facility: Gert Bosch Pretoria South Africa
city: ChangHua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Erenkoy Mental Health Hospital
city: Samsun
country: Turkey
facility: Liv Hospital
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: