Recruiting

Study on Esketamine and Aripiprazole with Antidepressants for Treatment-Resistant Depression in Elderly Patients

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for refractory major depressive disorder (RMDD) in elderly patients. RMDD is a type of depression that does not improve with standard treatments. The study will compare two treatments: esketamine nasal spray and aripiprazole, both used alongside an antidepressant. Esketamine is administered as a nasal spray, while aripiprazole is available in tablet form or as an oral solution.

The purpose of the study is to evaluate the effectiveness of these treatments over an eight-week period. Participants will continue taking their current antidepressant medication while adding either esketamine or aripiprazole to their treatment plan. The study aims to see if these additional treatments can help reduce symptoms of depression in patients who have not responded well to other antidepressants.

Throughout the study, participants will be monitored to assess their response to the treatment and any changes in their depressive symptoms. The study will also look at the safety of the treatments and their impact on the participants' quality of life. The trial will last for up to 32 weeks, with regular check-ins to track progress and any potential side effects. The goal is to find a more effective treatment option for elderly patients with RMDD who have not found relief with other medications.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 60-74 years and current antidepressant treatment status.
Eligibility requires a history of inadequate response to at least three different antidepressant treatments during the current depressive episode.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to one of two treatment groups. One group receives esketamine nasal spray, and the other receives aripiprazole, both in combination with a continued oral antidepressant.
Esketamine is administered via nasal spray, while aripiprazole is taken orally.
Step 3
Treatment phase
The treatment phase lasts for 8 weeks. During this period, participants continue their assigned treatment regimen.
The primary goal is to evaluate the effectiveness of the treatments in reducing depressive symptoms.
Step 4
Evaluation at week 8
At the end of 8 weeks, a clinical evaluation is conducted to assess the response to treatment.
The evaluation measures remission of depressive symptoms and overall clinical response using standardized scales.
Step 5
Extended observation
Participants showing positive response at week 8 may continue in the study for further observation up to 32 weeks.
The extended phase aims to monitor long-term effects and safety of the treatments.
Step 6
Final assessment
A final assessment is conducted at week 32 for participants who continue in the study.
This includes evaluating the sustained response to treatment and any potential side effects.

Who can join the trial?

6 criteria

Patients must be between 60 and 74 years old.
Patients should be currently receiving treatment with an antidepressant that includes an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin-norepinephrine reuptake inhibitors). This treatment should not be working well, meaning there is less than 25% improvement in symptoms, even after taking the right dose for at least 6 weeks.
The current antidepressant treatment must have been preceded by failure to respond to at least 3, but not more than 5, different treatments with antidepressant drugs during the same depressive episode. Each treatment should have been taken at the right dose for at least 6 weeks.
Patients should have tried at least 3 different types of antidepressants, each taken at the right dose for at least 6 weeks, without improvement in the current depressive episode.
Patients must be taking a single oral antidepressant on the first day before being randomly assigned to a treatment group in the study.
Patients who are taking a combination of antidepressants and/or additional treatment (other than aripiprazole) for the current depressive episode at the time of screening can participate in the study.

Who cannot join the trial?

3 criteria

Participants who are not elderly, meaning they are younger than 60 years old.
Participants who do not have a current episode of **refractory major depression disorder (RMDD)**, which means their depression has not improved with previous treatments.
Participants who are part of a vulnerable population, which refers to groups of people who might need special protection or care.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Verified
Hospital Vall d’Hebron
Barcelona, Spain
Verified
Virgen del Rocío University Hospital
Sevilla, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Esketamine Nasal Spray
is a medication used in this trial to help treat major depression that hasn't improved with other treatments. It is administered through the nose and works by affecting certain chemicals in the brain to help improve mood and relieve symptoms of depression.
Aripiprazole
is another medication used in this trial. It is an antipsychotic that can help improve mood and reduce symptoms of depression. It is taken in combination with an antidepressant to enhance its effects in treating major depression.
Antidepressant
is a type of medication that is used alongside esketamine nasal spray or aripiprazole in this trial. Antidepressants help to balance chemicals in the brain that affect mood and emotions, and they are a common treatment for depression.

What is already known about the treatment

Esketamine
Esketamine is administered as a nasal spray and is currently being studied for its effectiveness in treating refractory major depression disorder (RMDD) in elderly patients. It is recognized in medical literature as a promising option for individuals who have not responded to traditional antidepressants. The main therapeutic indication for esketamine is RMDD, where it is used in combination with other antidepressants. At the molecular level, esketamine works by modulating the NMDA receptor, which is part of the glutamate system in the brain, leading to rapid antidepressant effects. It is classified pharmacologically as an NMDA receptor antagonist.
Aripiprazole
Aripiprazole is taken orally and is being evaluated for its role in treating refractory major depression disorder (RMDD) in combination with other antidepressants. It is well-documented in medical literature as an adjunctive treatment for depression, particularly when other medications have not been effective. The primary therapeutic use of aripiprazole in this context is to enhance the effects of antidepressants in RMDD. Its mechanism of action involves partial agonism at dopamine D2 and serotonin 5-HT1A receptors, and antagonism at serotonin 5-HT2A receptors, which helps stabilize mood and improve depressive symptoms. Aripiprazole is classified as an atypical antipsychotic.

Investigated diseases

Refractory Major Depressive Disorder – This is a form of major depressive disorder that does not respond to standard treatments, such as antidepressant medications or psychotherapy. Individuals with this condition experience persistent and severe depressive symptoms that significantly impact their daily functioning and quality of life. The disorder is characterized by a lack of improvement despite trying multiple treatment options. Symptoms may include prolonged feelings of sadness, hopelessness, and a lack of interest in activities once enjoyed. It can also involve changes in sleep patterns, appetite, and energy levels. The condition requires ongoing management and evaluation to identify effective treatment strategies.