Alleviating Suicidality by Combining Psychotherapy and IM Ketamine for Rapid Treatment in the Emergency Department

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. The purpose of this study is to evaluate the effectiveness of combining an intramuscular (IM) injection of ketamine and Crisis Response Planning (CRP), a single, 45-60 minute psychological intervention with a therapist, to quickly reduce suicidal thoughts in patients treated in an emergency department (ED) prior to being admitted to the hospital.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation anticipated to be admitted as an inpatient at UH or CRDAMC based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient.

Able to read and write English.

Disqualifiers

Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors.

Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent.

The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider.

Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine Injectable Solution

    Drug

    1 mg.kg IM ketamine is administered after enrollment and randomization

  • Placebo Injection

    Other intervention

    Placebo is administered after enrollment and randomization

  • Crisis Response Plan

    Behavioral

    Crisis Response Planning is a collaborative, patient-centered psychosocial intervention that begins with a narrative assessment and concludes with the development of a personalized plan that outlines a series of self-regulatory strategies for managing acute emotional distress

  • Safety Planning

    Other intervention

    The Safety Planning intervention (provided as standard of care at discharge) includes a brief review of current suicide risk, provides patients with a suite of cognitive tools for avoiding future acute crises, and allows for a discussion and teach-back period to ensure patients' understanding of and willingness to use the plan

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Ketamine plus CRPExperimental treatment 2 interventions
Group B: Ketamine plus Safety plan controlExperimental treatment 2 interventions
Group C: Placebo plus CRPExperimental treatment 2 interventions
Group D: Placebo plus Safety plan controlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Depressive Symptoms Index - Suicidality Subscale (DSI-SS)

A 4 item scale scored from 0-3 for each item and summed to give a total between 0-12 with a higher score indication greater suicidal ideation.

Time frame
Baseline, 24 hours and 28 days

Secondary outcomes

1

Suicide Visual Analogue Scale (S-VAS)

A scale scored from 0=none to 100=extreme urge to commit suicide

Time frame
Baseline to 56 days
2

Beck Scale for Suicidal Ideation (SSI)

A scale with 19 possible items scored from 0-2 to give a possible score between 0-38 with a higher score indicating greater suicidal ideation. If the participant scores 0 (no indication of suicidal ideation) on questions 4 and 5, the survey is stopped at that point, otherwise the survey is continued.

Time frame
Baseline to 72 hours

Other outcomes

Sponsors and contacts

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