A Long-Term Extension Study for Participants With... — Clinical Trial Details | Blossom

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.

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Target Enrollment

183 participants

Study Type

Phase IV interventional

Design

Non-randomized

Registry

CTG / NCT04829318

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

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

Related Publications

Open AccessindividualPrimary

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study

This Phase IV single-arm long-term extension trial (n=183) found that the vast majority of patients with treatment-resistant depression who achieved remission with esketamine nasal spray (plus an antidepressant) did not relapse over 136 weeks of treatment, with side effects largely resolving the same day and no new safety concerns identified.

Published: February 27, 2026
Journal: European Neuropsychopharmacology
Authors: Reif, A., Anıl, Y. A., Bitter, I., Buyze, J., Frey, R., Godinov, Y., Haggström, L., Kambarov, Y., Nielsen, R., Oliveira-Maia, A., von Holt, C., Cubała, W., Young, A. H., DJ, Fu.

Ages

18 – 74

Sexes

Male & Female

BMI

Psychosis History

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

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