Clinical TrialMajor Depressive Disorder (MDD)EsketamineCompleted

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

Open-label single-group long-term extension (n=183) assessing long-term safety and tolerability of intranasal esketamine plus SSRI/SNRI in participants with treatment-resistant major depressive disorder who completed prior esketamine study.

Target Enrollment
183 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

This single-group, open-label long-term extension evaluates safety and tolerability of esketamine nasal spray administered weekly or every two weeks in combination with an ongoing SSRI/SNRI for up to two years in participants with treatment-resistant major depressive disorder who completed the prior maintenance study.

Assessments focus on adverse events and cardiovascular safety, with investigator-driven dose optimisation of SSRI/SNRI permitted; participants must have been benefiting from continued esketamine treatment and be medically stable at baseline.

Study Arms & Interventions

Esketamine

experimental

Open-label single-group continuation of esketamine nasal spray with ongoing SSRI/SNRI; up to 2 years or until commercial availability.

Interventions

  • Esketamine
    via Other• weekly or every 2 weeks

    Self-administered intranasal esketamine per prior study dosing and investigator judgment; dosing adjusted per local SmPC.

  • Compound
    via Other• ongoing

    Continued SSRI/SNRI (approved agent for depression in country); dose may be optimised or switched for tolerability.

Participants

Ages
18 – 74
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

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
Anima — Alken, Belgium
Mental Health Center - Rousse — Rousse, Bulgaria
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum — Sofia, Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD — Sofia, Bulgaria
Psychiatricka ambulance Saint Anne s.r.o. — Brno, Czechia
Psychiatricka ambulance, MUDr. Marta Holanova — Brno, Czechia
NeuropsychiatrieHK, s.r.o. — Hradec Králové, Czechia
A Shine S R O — Pilsen, Czechia
AD71 s.r.o. — Prague, Czechia
Medical Services Prague S R O — Prague, Czechia
Institut Neuropsychiatricke pece — Prague, Czechia
Mederon LTD at ARTES — Helsinki, Finland
Medizinisches Versorgungszentrum LiO GmbH — Berlin, Germany
Praxis Dr. med. Kirsten Hahn — Berlin, Germany
Klinikum Dortmund gGmbH — Dortmund, Germany
Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik — Freiburg im Breisgau, Germany
Klinische Forschung Hamburg — Hamburg, Germany
Oberhavel Kliniken GmbH — Hennigsdorf, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH — Mittweida, Germany
Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik — Pfaffenhofen, Germany
Somni Bene GmbH — Schwerin, Germany
Klinische Forschung Schwerin GmbH — Schwerin, Germany
Psychiatric Clinic 'Agios Charalampos' — Heraklion, Greece
University General Hospital of Rio Patras — Pátrai, Greece
G Papanikolaou Hospital of Thessaloniki — Thessaloniki, Greece
Processus Kft — Budapest, Hungary
Bugat Pal Korhaz — Gyöngyös, Hungary
Petz Aladar Megyei Oktato Korhaz — Győr, Hungary
Hospital Raja Permaisuri Bainun — Ipoh, Malaysia
University Malaya Medical Centre — Kuala Lumpur, Malaysia
Hospital Pengajar Universiti Putra Malaysia — Serdang, Malaysia
Hospital Tuanku Jaafar — Seremban, Malaysia
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
Osrodek Badan Klinicznych CLINSANTE S C — Torun, Poland
Cape Town Clinical Research Centre — Cape Town, South Africa
Gert Bosch Pretoria South Africa — Pretoria, South Africa
Severance Hospital Yonsei University Health System — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Changhua Christian Hospital — Changhua, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan
Chang Gung Memorial Hospital — Taoyuan District, Taiwan
Hacettepe University Medical Faculty — Ankara, Turkey (Türkiye)
Erenkoy Mental Health Hospital — Istanbul, Turkey (Türkiye)
Liv Hospital — Samsun, Turkey (Türkiye)

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