Depression - Major Depressive DisorderIODANCT07199179
Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia
An observational study of Depression - Major Depressive Disorder and Depression Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Disorder, Suicide
- How many people
- 456 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2024to 24 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population includes the 456 patients enrolled in the ASPIRE I and ASPIRE II studies.
Who may be able to join
- patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133)
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Keywords
- ESKETAMINE
- Medical subject headings
- Suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo
Secondary outcomes (5)
Psychological Pain
Psychological pain assessed using specific items from the Suicide Ideation and Behavior Assessment Tool (SIBAT). The SIBAT includes items from both modules 2 and 3 that describe various dimensions of psychological pain.
A higher score on the SIBAT indicates greater psychological pain, including emotional distress tied to suicidal ideation. A decrease in score suggests a reduction in psychological pain
Measured: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Hopelessness
Hopelessness is measured using the Beck Hopelessness Scale (BHS), which consists of 20 true/false items evaluating the patient's perception of hopelessness and their outlook on the future. A higher score indicates greater hopelessness. A decrease in the score indicates improvement in the patient's outlook and reduction in hopelessness.
Measured: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Severity of Suicidal Thoughts
Suicidal thoughts are assessed by a specific item on the Montgomery-Åsberg Depression Rating Scale (MADRS), which directly addresses the presence and severity of suicidal thoughts.
Higher score indicates more severe suicidal thoughts.
Suicidal severity is also assessed by The Clinical Global Impression-Severity Scale-Revised (CGI-SS-r). The scale evaluates both the presence and severity of suicidal thoughts and behaviors.
higher score indicates more severe suicidal ideation
Measured: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Frequency of Suicidal Ideation
- Patient Reported : The frequency of suicidal ideation is reported by the patient using the Suicide Ideation and Behavior Assessment Tool (SIBAT). This assesses how often the patient experiences suicidal thoughts throughout the study period.
A higher score indicates more frequent suicidal thoughts
- Clinician Reported : The clinician evaluates the frequency of suicidal ideation based on observations using the Suicide Ideation and Behavior Assessment Tool (SIBAT). A higher score indicates more frequent suicidal ideation observed by the clinician
Measured: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Depressive Symptoms Severity
Depressive symptoms are evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS), which includes 10 items assessing the severity of depression, including mood, anxiety, and cognitive symptoms.
A higher score indicates more severe depressive symptoms (0-6: No depression or very mild depression, 7-20: Mild to moderate depression, 21-34: Moderate to severe depression, 35+: Severe depression).
Measured: Assessed at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start24 Nov 2024
- Primary completion24 Nov 2025 (estimated)
- Study completion24 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199179
- Sponsor's protocol ID
- RECHMPL24_0018
- Acronym
- IODA
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia
- ClinicalTrials.gov ID
- NCT07199179
- Acronym / sponsor ID
- IODA / RECHMPL24_0018
- Keywords
- ESKETAMINE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 24 Nov 2025 (estimated)
- Study completion
- 24 Nov 2025 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes the 456 patients enrolled in the ASPIRE I and ASPIRE II studies.
Key inclusion criteria (1 listed)
- patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133)
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anhedonia
Time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo
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.
5 secondary outcomes
Psychological Pain
Time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Hopelessness
Time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Severity of Suicidal Thoughts
Time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Frequency of Suicidal Ideation
Time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Depressive Symptoms Severity
Time frame: Assessed at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Depression Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anhedonia (time frame: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.