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Active, not recruitingN/A

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

NCT07199179 · IODA · University Hospital, Montpellier

Closed to entry
Status
Not accepting participants
Not applicable
Phase
456
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study is looking at how intranasal esketamine (a nasal spray) can help reduce suicidal thoughts in patients with severe depression who are experiencing suicidal thoughts. Suicidal depression is a type of depression where people have active thoughts of suicide, which can be harder to treat with regular antidepressants. In fact, some people continue to have suicidal thoughts even after taking antidepressants. Esketamine has already shown promise in helping reduce suicidal thoughts quickly-often within 24 hours-and these effects can last for up to 25 days. Researchers believe esketamine may work by improving mood-related symptoms like loss of pleasure (called anhedonia) and feelings of hopelessness, which are linked to suicidal thinking. They also think that psychological pain, or emotional distress, might play a role in how well esketamine helps reduce suicidal thoughts. The goal of this study is to better understand how esketamine works to improve suicidal thoughts and whether certain factors (like mood symptoms or emotional pain) can predict which patients will benefit the most from this treatment. This study uses data from two earlier clinical trials, called ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133), that tested intranasal esketamine in patients with depression and suicidal thoughts. All data from these studies are publicly available and can be accessed and analyzed through the YODA (Yale University Open Data Access) platform, a database of clinical trial data that is accessible to external researchers.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Anhedonia

    Measured over Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133) Exclusion Criteria: * Not applicable

Where

1 study site

FacilityCityRegionCountry
Chu MontpellierMontpellierFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07199179 on ClinicalTrials.gov →

Last updated in the registry 2025-09-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits