Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients

NCT07153406 | Not Yet Recruiting Phase 3

• 1 other identifier: CESAR
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 9

Brief Summary

Phase III, open label, randomised, multicentre, blind for evaluators clinical trial to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole in elderly participants (\>60 years) who suffer from treatment-resistant major depressive

Conditions

Depressive Disorder

Keywords

Depressive Disorder; Moderate-severe depressive episode.; Antidepressants; Psychotropics

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Clinical response at week 8 after initiation of treatment, measured in terms of: * Remission of depressive symptoms; total score ≤10 on the MADRS (Montgomery-Asberg Depression Rating Scale )scale. * Adequate clinical response, if they show a reduction of ≥50% in the total score of the MADRS scale with respect to the initial score and a score ≤4 on the CGI severity scale. (Clinical Global Impression)

  At week 8

Secondary Outcomes (6)

• Safety profile of esketamine nasal spray and aripiprazole

  At week 32

• Clinical response

  At week 32

• Safety profile of esketamine nasal spray and aripiprazole

  At week 8

• Free of relapse

  At week 24, at week 32

• Score on the EuroQol-5D scale (www.euroqol.org)

  At day 1, at day 8, at day 15, at day 22, at week 5 to 8, at week 9 to 32, at week 34

Study Arms (2)

Esketamine

EXPERIMENTAL

Esketamine intranasal spray at flexible doses 28, 56 and 84 mg once or twice a week

Drug: Experimental regimen

aripiprazole

ACTIVE COMPARATOR

Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study

Drug: Control regimen

Interventions

Experimental regimen DRUG

Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week

Esketamine

Control regimen DRUG

Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study

aripiprazole

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 60-74 years
• To be receiving antidepressant treatment that includes an antidepressant at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose \[or local equivalent, if applicable\] for at least 6 weeks and have been increased to the dose maximum allowed
• Current antidepressant treatment must have been immediately preceded by failure to respond to at least 3, but not more than 5, different consecutive treatments (all within the same moderately severe depressive episode) with antidepressant drugs (AD) taken at an appropriate dose for at least least 6 weeks (3 antidepressant failures including the current one)
• To have been treated with at least 3 different classes of antidepressants between treatments taken at appropriate doses for at least 6 weeks without response in the current moderate to severe depressive episode (including current treatment with an antidepressant)
• To be taking a single oral antidepressant on day 1 before randomization
• Participants who, at the time of screening, are taking a combination of antidepressants and/or rescue treatment (other than aripiprazole) for the current moderate to severe depressive episode may participate in the study.

You may not qualify if:

• Treatment with drugs contraindicated with the use of esketamine and aripiprazole.
• Patients in whom a high risk of suicide is detected at the screening visit, according to the criteria established by Columbia University according to the C-SSRS evaluation
• Patients who are participating in another clinical trial with active treatment
• Patients who do not have the capacity to consent to participation in the trial or who do not have a representative to confirm their participation
• Hypersensitivity to any of the active ingredients of any of the branches of treatment, or to any of the excipients of its pharmaceutical form
• Patients in whom increased blood pressure or blood pressure intracranial fluid poses a serious risk

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (9)

Clínica Psiquiátrica Padre Menni

Pamplona, Navarre, 31014, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08014, Spain

Location

Hospital De La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Mare de Déu de La Mercè

Barcelona, 08042, Spain

Location

Hospital Sagrat Cor. Martorell

Barcelona, 08760, Spain

Location

Hospital Benito Menni y Fidmag Hermanas Hospitalarias

Barcelona, 08830, Spain

Location

Centro Sociosanitario Hermanas Hospitalarias de Palencia

Palencia, 34004, Spain

Location

Corporacion Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Benedicto Crespo Facorro, MD

  Fundación para la Gestión de la Investigación en Salud de Sevilla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara M Rosso Fernández, MD-PhD

CONTACT

+34955013414; claram.rosso.sspa@juntadeandalucia.es

Bianca Sánchez Barbero

CONTACT

+34955013491; biancasb85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind for evaluators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: September 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): January 15, 2029
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ES (9)