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

NCT07199179 | Active Not Recruiting

• 1 other identifier: RECHMPL24_0018
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression - Major Depressive Disorder; Depression Disorder; Suicide

Keywords

ESKETAMINE

Outcome Measures

Primary Outcomes (1)

• Anhedonia

  The primary outcome measure is the level of anhedonia, assessed by items 5, 7, 8, and 10 of the Montgomery-Åsberg Depression Rating Scale (MADRS). These items evaluate the loss of interest or pleasure in usual activities, a key symptom related to both depression and suicidal ideation. A higher score indicates greater anhedonia, meaning a more severe loss of interest or pleasure. A decrease in the score over time suggests improvement in the patient's ability to experience pleasure.

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

Secondary Outcomes (5)

• Psychological Pain

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

• Hopelessness

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

• Severity of Suicidal Thoughts

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

• Frequency of Suicidal Ideation

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

• Depressive Symptoms Severity

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes the 456 patients enrolled in the ASPIRE I and ASPIRE II studies.

You may qualify if:

• patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133)

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Chu Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: November 24, 2024
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)