Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

NCT04260607 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: NMCCL.2018.0011
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Current treatment for acutely suicidal patients are limited to hospitalization, psychotherapy, electro-convulsant therapy, or a combination of the aforementioned. However, this has added to the national boarding problem. Long term pharmacologic treatment for suicidal behaviors and mood stabilization has been studied in specific populations. In these populations, the decreases in suicidal ideation results from stabilization of the underlying psychiatric illness. Ketamine is most commonly used as an anesthetic with analgesic properties. It has been used off-label for pain management, procedural sedation, status epilepticus, and treatment resistant depression. It has been safely administered intravenously and well tolerated for chronic Post Traumatic Stress Disorder. It increases norepinephrine, dopamine, and serotonin through adrenergic neuron stimulation and prevention of catecholamine uptake. There is a strong corollary between stress and the development of depression and suicidal behaviors. It is proposed that the use of low dose intravenous ketamine may have benefit on the suicidal ideation of patients presenting to the Emergency Department.

Conditions

Suicide; Suicide Threat; Depression Severe

Keywords

ketamine

Outcome Measures

Primary Outcomes (6)

• Suicidal Severity - Clinical Efficacy

  Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.

  4 hour+/1 after infusion completion (performed for placebo and drug arms)

• Suicidal Severity - Clinical Efficacy

  Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.

  24-36 hours after infusion completion (performed for placebo and drug arms)

• Suicidal Severity - Efficacy at 1 Week

  Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.

  1week+/-1 day after infusion completion (performed for placebo and drug arms)

• Depression Symptoms - Clinical Efficacy

  Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.

  4 hours +/-1 after infusion completion (Performed for placebo and drug arms)

• Depression Symptoms - Clinical Efficacy

  Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.

  24-46 hours after infusion completion (Performed for placebo and drug arms)

• Depression Symptoms - Efficacy at 1 Week

  Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.

  1 week +/-1 day after infusion completion, performed for placebo and drug arms

Secondary Outcomes (1)

• Length of Hospital Stay

  Performed on medical record review at 1 week

Study Arms (2)

Experimental-Ketamine

EXPERIMENTAL

single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes

Drug: Ketamine Hydrochloride

Placebo-Saline

PLACEBO COMPARATOR

100ml Normal Saline infused over 40 minutes

Drug: Normal saline

Interventions

Ketamine Hydrochloride DRUG

Experimental Procedure 1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires. 2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes. 3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention 4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention. 5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.

Also known as: Experimental Arm

Experimental-Ketamine

Normal saline DRUG

Experimental Procedure 1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires. 2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes. 3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours 4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention. 5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.

Also known as: Placebo Comparator

Placebo-Saline

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 to 89 years old)
• Present with active SI
• Deemed to being admitted to inpatient psychiatric unit

You may not qualify if:

• Age \< 18 years old or \> 89 years old
• Currently presenting with psychosis as determined by mental health consultant
• Have a history of Cognitive disorder that would impair understanding of consent
• Have a personal/family history of Schizophrenia
• Currently pregnant or nursing
• Serious and unstable medical condition/problems
• Inability to medically clear
• Non-English Speakers
• Civilian Humanitarians
• Have previously enrolled in this study

Sponsors & Collaborators

• Naval Medical Center Camp Lejeune: lead

Study Sites (1)

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, 28547, United States

Location

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Related Links

• Violence Prevention \[Internet\]. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2018 \[cited 2018 July 1\].
• Medical care of the returning veteran. Up To Date.
• Knesper DJ. Continuity of care for suicide prevention and research: Suicide attempts and suicide deaths subsequent to discharge from the emergency department or psychiatry inpatient unit. 2010. Newton, MA: Suicide Prevention Resource Center. 68(6):758-
• Ketamine. Lexicomp; 31 January 2020.
• Janssen Research \& Development, LLC. A Long-term, Safety and Efficacy study of Intranasal Esketamine in Treatment resistant depression (SUSTAIN-2). 2017. ClinicalTrials.gov.
• Neurobiology of Suicide. 2018. ClinicalTrials.Gov.
• Pearson, 2018. Administering the Beck Scale Suicidal Ideation® (BSS®) Via Telepractice.

MeSH Terms

Conditions

Suicide

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only one patient had been assigned to the experimental group, and 0 patients to the placebo group. While data from the one patient was reported in the results with descriptive statistics, no inferential analysis could be performed.

Results Point of Contact

• Title: Naval Medical Center Camp Lejeune
• Organization: Naval Medical Center Camp Lejeune

nathan.butler@usmc.mil

317-691-1718

Study Officials

• Nathan H Butler, DO

  Naval Medical Center Camp Lejeune

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masked study (patient, healthcare provider, outcomes assessor) performed by pharmacy investigators not involved in study recruitment or assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Experimental versus Placebo

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: January 14, 2020
• Primary Completion: April 24, 2021
• Study Completion: February 16, 2022
• Last Updated: May 14, 2025
• Results First Posted: November 19, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)