Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities

NCT07120477 | Not Yet Recruiting Phase 4

• 1 other identifier: 89878225.0.0000.0068
• Study Type: interventional
• Target: 468
• Locations: 0 countries
• Sites: N/A

Brief Summary

Suicide is one of the leading causes of early death worldwide. In Brazil, suicide rates have been rising steadily over the past two decades, and most suicides occur in low- and middle-income countries where access to specialized care is limited. There is an urgent need for fast-acting, practical interventions that can be delivered in public emergency settings. Two promising approaches have emerged: esketamine, a medication that can rapidly reduce suicidal thoughts within hours, and Crisis Response Planning (CRP), a brief session in which a trained clinician works with the person to create a personalized written plan for managing future suicidal crises. The goal of this clinical trial is to learn if esketamine or Crisis Response Planning (CRP), each added to enhanced treatment as usual (eTAU), can prevent future suicide-related events compared to eTAU alone in adolescents and adults aged 14 years or older who recently attempted suicide or have severe suicidal thoughts. The main questions it aims to answer are: Does a single esketamine infusion plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Does a single session of Crisis Response Planning plus eTAU lower the risk of a new suicide-related event compared to eTAU alone over 12 months? Which approach leads to faster or more lasting improvements in suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life? Are these interventions feasible, acceptable, and cost-effective within a public health system? Researchers will compare three groups to see which approach works best to prevent suicide attempts, suicide-related hospitalizations, and suicide deaths over one year. A total of 468 participants will be randomly assigned in equal numbers (156 per group) to one of three groups: Esketamine group: receive a single intravenous esketamine infusion (0.50 mg/kg given over 40 minutes) in a monitored medical setting with continuous heart rate, blood pressure, and oxygen monitoring, plus eTAU. A physician will be present throughout. Participants will be observed for up to 24 hours before discharge. Crisis Response Planning group: complete one 20-to-45-minute session with a trained clinician to build a personal crisis plan that includes warning signs, coping strategies, reasons for living, support contacts, and emergency resources. Participants will leave with a written and digital copy of their plan, plus eTAU. Enhanced treatment as usual (eTAU) group: receive standard emergency care, safety counseling about access to lethal means, connection to the local mental health network (including Psychosocial Care Centers and primary care), and a scheduled psychiatric follow-up appointment within 7 days. Participants will: Complete health questionnaires about suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life at 11 time points over one year (at enrollment, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year) Provide a blood sample at the start of the study for exploratory analyses of biological markers that may be related to treatment response Use a smartphone app to report their mood, thoughts, and emotions four times a day for four weeks after enrollment Be monitored for safety and adverse events throughout the entire study period The study takes place in the public emergency network of Indaiatuba, São Paulo, Brazil (population approximately 256,000), and is designed to reflect real-world clinical conditions. Participants who experience a new suicide-related event during the study will be offered an open-label rescue treatment combining esketamine and Crisis Response Planning, and will continue to be followed for the remainder of the year. The study also includes an evaluation of how well these interventions can be adopted and sustained within Brazil's public mental health system, including assessments of acceptability, feasibility, and cost-effectiveness.

Conditions

Suicide Prevention; Ketamine; Crisis Response Plan

Keywords

Suicide Prevention; Ketamine; Crisis Response Plan

Outcome Measures

Primary Outcomes (1)

• Time to first event

  Time from randomization to the first occurrence of a composite suicide-related event, defined as any suicide attempt (actual, interrupted, or aborted) assessed via the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide-preventive psychiatric admission, suicide death, or self-injury requiring emergency department care. Events are ascertained through structured C-SSRS interviews at each follow-up visit, medical record linkage, and routine clinical surveillance. Analysis uses Cox proportional-hazards models with Holm-Bonferroni family-wise error control for two co-primary comparisons (esketamine + eTAU vs. eTAU; CRP + eTAU vs. eTAU).

  One year from baseline enrollment

Secondary Outcomes (12)

• Total Suicide-Related Events (Count)

  12 months from randomization

• Suicidal Ideation Severity (Beck Scale for Suicide Ideation)

  Baseline, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year

• Suicidal Ideation and Behavior (Columbia-Suicide Severity Rating Scale)

  Baseline, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year

• Depressive Symptoms - Self-Reported (Patient Health Questionnaire-9)

  Baseline, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year

• Depression Severity - Clinician-Rated (Montgomery-Åsberg Depression Rating Scale)

  Baseline, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, and 1 year

Other Outcomes (5)

• Cost-Effectiveness Analysis

  12 months from randomization

• Implementation Outcomes - Acceptability, Appropriateness, and Feasibility (AIM/IAM/FIM)

  4 weeks, 24 weeks, and 1 year

• Frequency and Severity of Adverse Events

  Continuously throughout study participation, up to 1 year

Study Arms (3)

Esketamine plus optimized usual treatment

EXPERIMENTAL

Single esketamine infusion (0.5 mg/kg over 40 minutes) plus optimized usual treatment (early psychiatric follow-up within one week)

Drug: Intravenous Esketamine

Crisis Response Planning plus Optimized Usual Treatment

EXPERIMENTAL

Crisis Response Planning intervention (structured safety planning) plus optimized usual treatment (early psychiatric follow-up within one week)

Other: Crisis Response Planning intervention (structures safety planning)

Optimized Usual Treatment Only

ACTIVE COMPARATOR

Optimized usual treatment alone (enhanced standard care with early psychiatric follow-up within one week)

Drug: Intravenous Esketamine; Other: Crisis Response Planning intervention (structures safety planning)

Interventions

Intravenous Esketamine DRUG

Single-session intravenous esketamine infusion (0.5 mg/kg) administered over 40 minutes in a medical setting with continuous monitoring of vital signs, blood pressure, ECG, and oxygen saturation for 4 hours post-infusion. Administration supervised by trained medical staff with emergency protocols available. Participants will be discharged 24 hours post-infusion if no clinical complications arise, with ambulatory evaluations at 48 hours, 72 hours, and 7 days post-infusion.

Esketamine plus optimized usual treatment; Optimized Usual Treatment Only

Crisis Response Planning intervention (structures safety planning) OTHER

Collaborative safety planning intervention delivered by trained clinical psychologists in 20-45 minute sessions. Participants create personalized, written crisis response plans identifying warning signs of emotional distress, internal coping strategies, social support contacts, professional resources, and means restriction methods. The intervention follows a structured format focusing on practical crisis management tools that participants can implement during suicidal crises.

Crisis Response Planning plus Optimized Usual Treatment; Optimized Usual Treatment Only

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14 years or older
• Presentation to a public emergency service (ED/UEU) within the study municipality
• Recent suicide attempt within the past 30 days (actual, interrupted, or aborted attempt)
• Current severe suicidal ideation, defined as endorsement of items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) screening version, indicating active suicidal ideation with specific plan and/or method, or active suicidal ideation with intent to act
• Residency in the catchment area of the study municipality (Indaiatuba, São Paulo, Brazil), enabling completion of follow-up assessments
• 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)
• No clinical decision for involuntary or voluntary hospitalization in a psychiatric inpatient unit following the index emergency department evaluation

You may not qualify if:

• Contraindications to esketamine, including: aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or known hypersensitivity to esketamine or ketamine
• Current pregnancy or breastfeeding (confirmed by rapid pregnancy test in the emergency setting for female participants of childbearing potential)
• Medical instability requiring intensive care unit (ICU) admission without feasible study follow-up
• Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder), current acute psychosis, or current acute manic episode precluding informed participation
• Severe substance use disorder compromising capacity for treatment adherence, as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
• Inability to maintain contact for follow-up assessments, including participants whose residential address is located outside the study municipality

Sponsors & Collaborators

• University of Sao Paulo: lead
• Yale University: collaborator
• University of Vermont: collaborator
• University of Pittsburgh: collaborator

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MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Rodolfo F Damiano, M.D., Ph.D.

CONTACT

+5511933300360; damianorf@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a pragmatic trial in which participants and treating clinicians are necessarily unblinded due to the nature of the interventions (intravenous esketamine infusion, face-to-face Crisis Response Planning session, and enhanced treatment as usual). Outcome assessors are blinded to treatment allocation; they are trained not to inquire about treatment received and to terminate the assessment if a participant voluntarily reveals their assigned group, with reassignment to an alternative blinded assessor. Data analysts are also blinded: they receive coded datasets labeled Groups A, B, and C without treatment identification until completion of the primary analyses. Emergency unblinding is restricted to serious safety concerns requiring knowledge of allocation for appropriate clinical management, following a pre-specified protocol approved by the Ethics Committee. All unblinding events are documented with detailed justification and reported to the Ethics Committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doc Student

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share