Recruiting PHASE2, PHASE3 Suicide

New treatment option for Suicide

Official title Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

ClinicalTrials.gov ID: NCT05696691

What this study is testing

What is Ketamine Hydrochloride?

Ketamine Hydrochloride is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for suicide.

Also referred to as Ketamine.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation.
  • Patient cleared for admission to the University Hospital inpatient psychiatric unit.
  • Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from...
  • Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible.
  • Able to read and write English.

You likely can't join if

  • Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other...
  • Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety).
  • The patient is not capable of understanding the research procedures and providing informed consent for themselves.
  • Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone).
  • Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than...
  • Injuries requiring procedural sedation.
See the full eligibility criteria
Who can join
  • Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation.
  • Patient cleared for admission to the University Hospital inpatient psychiatric unit.
  • Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for...
  • Individuals presenting to the ED for other complaints but found to have suicidal ideation necessitating admission will also be eligible.
  • Able to read and write English.
What rules you out
  • Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms.
  • Acute intoxication with clinically significant symptoms (as defined by the attending clinician's assessment of patients' clinical sobriety).
  • The patient is not capable of understanding the research procedures and providing informed consent for themselves.
  • Lack of reliable means to be available for follow-up assessments (e.g, working mobile phone).
  • Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute.
  • Injuries requiring procedural sedation.
  • Pregnancy or breast feeding.
  • Known hypersensitivity to ketamine.
  • Legal or illegal use of ketamine in the previous 90 days.
  • End-stage or severe cardiovascular (e.g., ACS or decompensated heart failure), liver, or kidney disease.
  • Patient is a prisoner.
  • Patient is physically restrained or actively under custody of law enforcement. Once a patient is no longer under custody of law enforcement or physically restrained, the patient may be considered eligible and may...

The study team makes the final eligibility decision.

Where it's taking place

  • San Antonio, Texas, United States

Compensation & support

A stipend or compensation may be offered.

Compensation likely.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.