Can a single infusion or a crisis plan stop suicide? new trial aims to find out
NCT ID NCT07120477
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 6 times
Summary
This study tests two fast-acting approaches to prevent suicide in teens and adults who recently attempted suicide or have severe suicidal thoughts. One group receives a single intravenous dose of esketamine, another gets a one-on-one crisis planning session, and a third gets enhanced usual care. Researchers will track which approach best prevents future suicide attempts, hospitalizations, or deaths over one year. The trial takes place in public emergency rooms in Brazil and includes 468 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Esketamine (intravenous infusion)
- What this could lead to
- If successful, this could provide a fast-acting, practical option to reduce suicide risk in public emergency settings, especially in low- and middle-income countries.
- What could go wrong
- This is a single infusion study; effects may be short-lived. The trial is not yet recruiting, and results may not generalize beyond the specific Brazilian public health context.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 478 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must meet all of the following criteria: 1. Age 14 years or older. 2. Presentation to a participating public emergency service (ED/UEU) in Indaiatuba, São Paulo, Brazil. 3. Either of the following: 1. A suicide attempt within the previous 30 days, including an actual, interrupted, or aborted attempt; OR 2. Current severe suicidal ideation, defined as endorsement of item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) screening version: active suicidal ideation with intent to act, without a specific plan (item 4), or with a specific plan (item 5). Non-suicidal self-injury alone does not satisfy this criterion. 4. Residence within the study catchment area in Indaiatuba, enabling completion of follow-up assessments. 5. Ability to provide written informed consent for participants aged 18 years or older, or written assent with written informed consent from a parent or legal guardian for participants aged 14-17 years. 6. No clinical decision for voluntary or involuntary admission to a psychiatric inpatient unit following the index emergency evaluation. Exclusion Criteria: Participants meeting any of the following criteria are excluded: 1. A contraindication to esketamine, including aneurysmal vascular disease, arteriovenous malformation, a history of intracerebral hemorrhage, or known hypersensitivity to esketamine or ketamine. 2. Current pregnancy or breastfeeding. Pregnancy testing is performed in the emergency setting for participants with pregnancy potential; breastfeeding status is established by clinical history. 3. Medical instability requiring intensive care unit admission without feasible study follow-up. 4. A primary psychotic disorder, such as schizophrenia or schizoaffective disorder; or current acute psychosis or an acute manic episode that precludes informed participation. 5. Any of the following substance-related conditions: 1. Acute intoxication at assessment that precludes valid informed consent, reliable administration of the C-SSRS, or safe delivery of the assigned intervention, as determined by the attending physician. Re-screening is permitted after clinical recovery if all other eligibility criteria remain satisfied. For participants qualifying on the basis of a recent suicide attempt, that attempt must still fall within the preceding 30 days. 2. High-risk hallucinogen involvement, defined as a WHO ASSIST substance-specific involvement score of 27 or higher for the hallucinogen category, item (h). 3. A documented history of ketamine use disorder identified during baseline psychiatric assessment. 6. Inability to maintain contact for follow-up assessments. Substance-use assessment: The Brazilian Portuguese WHO ASSIST is administered during baseline eligibility assessment. Substance-specific involvement scores are calculated from questions 2 through 7, with question 5 omitted for tobacco. Questions 1 and 8 do not contribute to these scores. High risk is defined as a score of 27 or higher. The ASSIST hallucinogen category does not identify ketamine exposure specifically; relevant substance history is also assessed clinically. Except for the high-risk hallucinogen criterion above, ASSIST scores do not automatically exclude participation. Among eligible participants, high-risk involvement with alcohol or other non-tobacco substances is recorded for exploratory moderation analyses and to inform clinical care.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Prefeitura de Indaiatuba
RECRUITINGIndaiatuba, São Paulo, Brazil
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