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

NCT ID: NCT07120477

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

Brief Summary

1. Background Suicide is a major public health challenge with over 800,000 deaths annually worldwide. Brazil experienced a concerning 57% increase in suicide rates between 2000-2019, highlighting urgent need for effective prevention strategies. This study evaluates two promising interventions: esketamine (rapid-acting pharmacological treatment) and Crisis Response Planning (CRP, evidence-based psychological safety planning approach) in a real-world Brazilian public health setting.

2. Study Design

Pragmatic randomized controlled trial with hybrid implementation-effectiveness design comparing three approaches in emergency departments across two Brazilian cities with combined population of 310,000:

• Group A: Single esketamine infusion (0.5 mg/kg over 40 minutes) + optimized usual treatment (OUT)
• Group B: Crisis Response Planning + OUT
• Group C: OUT alone (enhanced control)

3. Participants

Adults and adolescents (≥14 years) presenting with high suicide risk defined as:

• Recent suicide attempts within 30 days (actual, interrupted, or aborted)
• Severe suicidal ideation (Columbia-Suicide Severity Rating Scale questions 4-5 positive)
• Non-suicidal self-harm requiring emergency medical attention

4. Target enrollment: ~272 participants per group (816 total). Key exclusions: esketamine contraindications (cardiovascular disease, aneurysms), psychotic disorders, severe substance use disorders, pregnancy/lactation, inability to consent.

5. Interventions

1. Esketamine Group: IV infusion administered in medical setting with continuous 4-hour monitoring (pulse, blood pressure, ECG, oxygen saturation). Trained medical staff and emergency protocols available.

2. Crisis Response Planning: Collaborative intervention delivered by trained clinical psychologists. 20-45 minute sessions creating personalized, written safety plans identifying warning signs, internal coping strategies, social support contacts, professional resources, and means restriction.

3. Optimized Usual Treatment: Enhanced standard care including guaranteed psychiatric follow-up appointment within one week through municipal mental health services (CAPS - Psychosocial Care Centers).

6. Primary Outcome Repeated suicide-related events over one year including suicide attempts, interrupted attempts, suicide-prevention hospitalizations, deaths by suicide, and non-suicidal self-harm requiring medical attention.

7. Comprehensive Data Collection

1. Biomarkers: 10mL venous blood samples (2 EDTA tubes) collected at baseline by senior clinical nurses. Comprehensive laboratory analysis including complete blood count, metabolic panel, vitamins (B1, B2, B6, B12, B9, D, K), hormones (TSH, T3, T4, testosterone, DHEA, prolactin), inflammatory markers (CRP), brain-derived neurotrophic factor (BDNF), platelet monoamine oxidase (MAO), minerals (iron, ferritin, magnesium, zinc, selenium), and lipid profiles. Samples processed within 24 hours and stored at -80°C for analysis.

2. Clinical Assessments: Comprehensive evaluations at 11 time points (baseline, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, 1 year) using validated instruments: Columbia-Suicide Severity Rating Scale (C-SSRS), depression scales (PHQ-9, MADRS), anxiety (GAD-7), quality of life (SF-36v2), impulsivity (BIS-11), trauma history (MACE), substance use (ASSIST), sleep quality (PSQI), and additional psychosocial measures.

3. Ecological Momentary Assessment: Real-time data collection via smartphone application for consenting participants. Six daily prompts assessing mood, suicidal thoughts, and emotional states using validated scales. Previous research demonstrates safety and high compliance rates in suicide research populations.

8. Secondary Outcomes

• Time to new suicidal crisis or psychiatric emergency
• Changes in depression and anxiety severity scores
• Quality of life and functional outcome improvements
• Treatment response variability by demographic factors (age, gender, socioeconomic status)
• Comprehensive cost-effectiveness analysis including direct medical costs and indirect productivity losses
• Patient and clinician satisfaction with treatment modalities
• Implementation barriers and facilitators using Consolidated Framework for Implementation Research (CFIR)
• Biomarker predictors of treatment response

9. Clinical Significance This represents the first large-scale, real-world direct comparison of rapid-acting pharmacological (esketamine) versus evidence-based psychological (CRP) interventions for suicide prevention within a public health system. Results will provide crucial evidence for clinical practice guidelines and inform implementation of these interventions in Brazil and similar global contexts. The pragmatic design ensures findings are directly applicable to routine emergency department practice, while comprehensive biomarker analysis may identify biological predictors of treatment response to personalize suicide prevention approaches.

Detailed Description

Additional Open-Label Study for Recurrent Suicide: Any participant who experiences a recurrent suicidal crisis-thus meeting the primary outcome of the study-will be eligible to participate in a secondary open-label study (ketamine + CRP + OUT). In this phase, participants will be treated and followed for the remainder of the 1-year period.

Conditions

Suicide Prevention; Ketamine; Crisis Response Plan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Esketamine plus optimized usual treatment

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

Group Type: EXPERIMENTAL

Intravenous Esketamine

Intervention Type: 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.

Crisis Response Planning plus Optimized Usual Treatment

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

Group Type: EXPERIMENTAL

Crisis Response Planning intervention (structures safety planning)

Intervention Type: 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.

Optimized Usual Treatment Only

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

Group Type: ACTIVE_COMPARATOR

Intravenous Esketamine

Intervention Type: 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.

Crisis Response Planning intervention (structures safety planning)

Intervention Type: 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.

Interventions

Intravenous Esketamine

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.

Intervention Type: DRUG

Crisis Response Planning intervention (structures safety planning)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 14 years
• Recent suicide attempt within 30 days (actual, interrupted, or aborted)
• Severe suicidal ideation (positive response to questions 4 or 5 on Columbia-Suicide Severity Rating Scale screening version)
• Non-suicidal self-harm requiring medical attention in emergency department setting
• Resident of Jaguariúna, Indaiatuba, or surrounding areas
• Able to provide informed consent (or assent with guardian consent for minors)
• Not requiring long-term psychiatric hospitalization after emergency evaluation

Exclusion Criteria

• Medical conditions contraindicated for esketamine use (aneurysmal vascular disease, arteriovenous malformation, intracerebral hemorrhage, known hypersensitivity to esketamine)
• Need for intensive care unit admission without possibility of later study participation
• Severe substance use disorders interfering with protocol adherence
• Psychotic disorders
• Lack of stable housing or inability to be contacted for follow-up assessments
• History of non-response to esketamine or previous enrollment in esketamine studies
• Pregnancy or breastfeeding
• Inability to provide informed consent due to cognitive impairment or explicit refusal to participate

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Furlan Damiano

Post-doc Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

damianorf@usp.br

+5511933300360

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Other Identifiers

89878225.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id