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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Fundació Hospitalàries Martorell	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Corporacion Sanitaria Parc Tauli	Sabadell	Spain
Fhvosznh Htwyecifiudvp Bmainpizh Nvsi	Barcelona	Spain
Firvamkc Hkycehktdsoih Smzl Btr	Sant Boi De Llobregat	Spain
Fhguxwqm Huikxoaafadjx Bdeigjksf	Barcelona	Spain
Fztohdge Hdogkdbpwwbqb Snnh Bzhxlnbomzobqy	Granollers	Spain
Hbcubacn Db Lq Sdxyh Cnev I Snon Pzk	Barcelona	Spain
Hgjdolyp Vjdl dzizxjev	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	15.01.2025

Trial locations

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.

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.

Trial ID:

2024-512672-34-00

Protocol code:

CESAR

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?