Active not recruitingOBSERVATIONAL

Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia

This study aims to understand how a nasal spray called esketamine helps reduce suicidal thoughts in people with severe depression. Some people with depression continue to have suicidal thoughts even after trying regular antidepressants. Esketamine has shown promise in quickly lowering these thoughts, often within 24 hours, with effects lasting for weeks. Researchers believe it might work by improving mood or how a person experiences emotional pain. The study is particularly interested in whether factors like emotional distress or feeling unable to enjoy things (anhedonia) can predict who will benefit most from this treatment. This research uses information from two earlier studies, ASPIRE I and ASPIRE II, which looked into esketamine for similar patients. The data is publicly available for analysis by researchers.

At a glance

Status

Active not recruiting

Sponsor

University Hospital, Montpellier

Enrolment target

456

Start

24 Nov 2024

Estimated completion

24 Nov 2025

Depression - Major Depressive Disorder Depression Disorder Suicide

What is this study about?

This research is looking at depression, specifically a type where people have active suicidal thoughts. This kind of depression can be particularly challenging to treat with standard antidepressants, and some individuals continue to struggle with suicidal feelings even after trying various treatments.

The study focuses on a treatment called esketamine, which is given as a nasal spray. Previous studies have suggested that esketamine can quickly help reduce suicidal thoughts, often within a day, and these positive effects might last for up to 25 days. Researchers want to understand better *how* esketamine works. They think it might help by improving symptoms related to mood, such as anhedonia (which means a loss of pleasure in things you once enjoyed) and feelings of hopelessness. They also believe that the level of 'psychological pain' – or emotional distress – a person experiences might be important in how well esketamine works for them.

The main goal of this particular study is to explore these connections. By looking at information from two previous clinical trials (ASPIRE I and ASPIRE II), researchers hope to learn if certain factors, like existing mood symptoms or emotional pain levels, can predict which patients are most likely to benefit from esketamine. This will help them understand who might respond best to this treatment in the future.

Key takeaways

This study uses existing data, not new patients.
It's about a nasal spray called esketamine for severe depression with suicidal thoughts.
Researchers want to know who benefits most and why.
The study explores the link between pain, pleasure, and esketamine's effects.
The goal is to improve future treatments for depression.

Who may be eligible?

This study is not recruiting new patients. Instead, it is a research project that uses information (data) from two previous clinical trials, called ASPIRE I and ASPIRE II. If you were one of the patients who took part in either of those two earlier studies, then your anonymous data is part of the information being looked at in this current research.

Basically, if you have participated in the ASPIRE I or ASPIRE II trials, your information is being used in this analysis. If you did not participate in those trials, you are not involved in this specific research study. All participants in the original studies were aged between 18 and 64 years old, and the studies included both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I was a participant in the ASPIRE I or ASPIRE II clinical trials.
I was aged between 18 and 64 when I participated in one of those trials.
I experienced severe depression with suicidal thoughts during those trials.
I received intranasal esketamine as part of those trials.

Answer every question to see your result.

What does participation involve?

This study does not involve new patients or any direct participation. It is a research project that uses existing, anonymised information collected from two previous clinical trials called ASPIRE I and ASPIRE II. This means no visits, no new medication, no assessments, and no follow-up for new individuals are required. The researchers are simply analysing data that has already been collected from those past studies.

Potential risks and benefits

Since this study is purely an analysis of existing, anonymous patient data, there are no direct risks or benefits to individual patients. The information used has already been collected, and patient identities are protected. The potential benefit of this research is a better understanding of how esketamine works and who might benefit most from it, which could lead to improved care for people with severe depression and suicidal thoughts in the future. As no new participation is involved, there is no right to withdraw for individuals.

Locations (1)

Chu Montpellier
Verified postcode
Montpellier, France

Common questions

What is esketamine?

Esketamine is a medicine given as a nasal spray, which has been shown to help reduce severe depression symptoms, especially suicidal thoughts, in some people.

Is this a new treatment?

Esketamine is an approved treatment, and this study is using existing information from previous trials that tested its effects.

Who is this study for?

This study is looking at information (data) from people who took part in two earlier clinical trials, called ASPIRE I and ASPIRE II, which investigated esketamine for depression with suicidal thoughts.

Will I have to do anything if I'm in this study?

No, this study is just looking at existing data. No new patient involvement, visits, or treatments are required.

Why is this research important?

It helps doctors and researchers understand better how esketamine works, and which patients might get the most benefit from it, potentially leading to more effective treatments for severe depression in the future.