Comparison of Esketamine Nasal Spray vs.Aripiprazole in T... | NCT07153406

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Experimental regimen	Drug	Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week	Esketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety profile of esketamine nasal spray and aripiprazole	Determination of the safety profile of esketamine nasal spray and aripiprazole in patients free of relapse at week 32, according to the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 throughout the study.	At week 32

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Name	Role	Phone	Extension	Email
Clara M Rosso Fernández, MD-PhD	Contact	+34955013414		claram.rosso.sspa@juntadeandalucia.es
Bianca Sánchez Barbero	Contact	+34955013491		biancasb85@gmail.com

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders