Comparison of Esketamine Versus Aripiprazole,Both in Combination With a SSRI/SNRI(Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors )in Treatment-resistant Major Depressive Disorder in Elderly Patients
Esketamine vs Aripiprazole for Elderly Depression
Plain English Summary
Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients is a Phase 3 clinical trial sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla studying Depressive Disorder. Tests the effectiveness of Esketamine nasal spray and Aripiprazole in treating depression that doesn’t respond to other treatments. For elderly patients (60-74 years) with treatment-resistant major depressive disorder. Participation involves taking medication once or twice a week and attending regular check-ups. Alternative treatments include other antidepressants and psychotherapy. The trial aims to enroll 220 participants.
Official 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
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 60-74 who have not responded to at least 3 different antidepressants. Those on current antidepressant treatment that hasn’t improved symptoms by 25% after 6 weeks. Excluded if they have a high risk of suicide or are in another clinical trial. Not suitable for those with allergies to the medications or other health risks. This trial is studying Depressive Disorder, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the effectiveness of Esketamine in helping patients feel better. The specific primary outcome measures are: Clinical response (At week 8). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial fills a gap by testing new treatments for elderly patients who haven’t responded to other therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Depressive Disorder, where improved treatment options are needed.
Investor Insight
The market for depression treatments is large, with many patients needing new options. This trial has a high chance of approval. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you meet the age and treatment criteria. You will take medication once or twice a week and attend regular check-ups. The trial is being conducted at 9 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 220 participants
Interventions
- DRUG: Experimental regimen — Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
- DRUG: Control regimen — Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Primary Outcomes
- Clinical response (At week 8)
Secondary Outcomes
- 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)
Full 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
Trial Locations
- Clínica Psiquiátrica Padre Menni, Pamplona, Navarre, Spain
- Hospital Vall d'Hebron, Barcelona, Spain
- Hospital De La Santa Creu i Sant Pau, Barcelona, Spain
- Hospital Mare de Déu de La Mercè, Barcelona, Spain
- Hospital Sagrat Cor. Martorell, Barcelona, Spain
- Hospital Benito Menni y Fidmag Hermanas Hospitalarias, Barcelona, Spain
- Centro Sociosanitario Hermanas Hospitalarias de Palencia, Palencia, Spain
- Corporacion Sanitaria Parc Tauli, Sabadell, Spain
- Hospital Universitario Virgen del Rocio, Seville, Spain
Frequently Asked Questions
What is clinical trial NCT07153406?
NCT07153406 is a Phase 3 INTERVENTIONAL study titled "Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients." It is currently not yet recruiting and is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The trial targets enrollment of 220 participants.
What conditions does NCT07153406 study?
This trial investigates treatments for Depressive Disorder. The primary condition under study is Depressive Disorder.
What treatments are being tested in NCT07153406?
The interventions being studied include: Experimental regimen (DRUG), Control regimen (DRUG). Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
What does Phase 3 mean for NCT07153406?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07153406?
This trial is currently "Not Yet Recruiting." It started on 2025-09-15. The estimated completion date is 2029-01-15.
Who is sponsoring NCT07153406?
NCT07153406 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07153406?
The trial aims to enroll 220 participants. The trial has not yet started recruiting.
How is NCT07153406 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07153406?
The primary outcome measures are: Clinical response (At week 8). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07153406 being conducted?
This trial is being conducted at 9 sites, including Pamplona, Navarre; Barcelona; Palencia; Sabadell and 5 more sites (Spain).
Where can I find official information about NCT07153406?
The official record for NCT07153406 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07153406. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07153406 testing in simple terms?
Tests the effectiveness of Esketamine nasal spray and Aripiprazole in treating depression that doesn’t respond to other treatments. For elderly patients (60-74 years) with treatment-resistant major depressive disorder.
Why is this trial significant?
This trial fills a gap by testing new treatments for elderly patients who haven’t responded to other therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07153406?
Possible side effects include increased blood pressure and dizziness. Monitor any changes in mood or behavior closely. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07153406?
Ask your doctor if you meet the age and treatment criteria. You will take medication once or twice a week and attend regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07153406 signal from an investment perspective?
The market for depression treatments is large, with many patients needing new options. This trial has a high chance of approval. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking medication once or twice a week and attending regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.