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NMDA Receptor Antagonist
Ketamine for Suicidal Thoughts (LDK-SI Trial)
N/A
Waitlist Available
Research Sponsored by Brooke Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
LDK-SI Trial Summary
This trial will study ketamine as a possible treatment for suicidal ideation. Patients will be randomly assigned to receive ketamine, diphenhydramine, or placebo, and then monitored for changes.
Who is the study for?
This trial is for adults aged 18-74 who arrive at the emergency department with acute suicidal thoughts and a SADPERSONS score of 5 or more. It's not for those allergic to ketamine or diphenhydramine, pregnant or breastfeeding women, individuals outside the weight limits, with certain heart conditions, unstable vital signs, mental status issues, non-English speakers, or severe chronic diseases.Check my eligibility
What is being tested?
The study tests if ketamine can help reduce acute suicidal ideation in the ER. Participants are randomly assigned to receive either ketamine (the intervention), diphenhydramine (active control), or a placebo (inactive control). Their responses are monitored during their ER stay and at later check-ups.See study design
What are the potential side effects?
Ketamine may cause side effects like disorientation, nausea, increased blood pressure and heart rate changes. Diphenhydramine can lead to drowsiness, dry mouth and sometimes blurred vision. The severity of side effects varies from person to person.
LDK-SI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Beck Scale for Suicidal Ideation
LDK-SI Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: KetamineExperimental Treatment1 Intervention
active arm
Group II: SalinePlacebo Group1 Intervention
placebo
Group III: DiphenhydraminePlacebo Group1 Intervention
sham arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Find a Location
Who is running the clinical trial?
Brooke Army Medical CenterLead Sponsor
118 Previous Clinical Trials
26,471 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to ketamine or diphenhydramine.I do not speak English.I am a woman of childbearing age and refuse to take a pregnancy test.I have a mass or abnormal blood vessel in my brain.I am willing to participate and can provide informed consent.You have experienced episodes of seeing or hearing things that aren't really there, or having thoughts that are not based in reality.I need oxygen for a lung condition, have liver cirrhosis, or need dialysis for kidney disease.My doctor thinks I might need to be restrained for safety.My weight is either over 115 kg or under 45 kg.I am between 18 and 75 years old and have thoughts of harming myself, with a high risk score.You are currently experiencing severe mental confusion or hallucinations.I have heart disease, heart failure, or a history of irregular heartbeats.I have had issues with high pressure in my brain.You are experiencing confusion or are under the influence of drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Saline
- Group 2: Ketamine
- Group 3: Diphenhydramine
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does my profile meet the criteria to join this research project?
"Qualified applicants must have a history of suicidal ideation and be between 18-75 years old. 53 individuals in total are being sought for this medical study."
Answered by AI
What is the participant size of this research trial?
"This clinical trial is not accepting new patients at this time, having been posted on June 1st 2015 and last updated February 13th 2015. For those searching for other studies, 403 trials related to suicide are enrolling participants while 105 research projects concerning Ketamine have open spots."
Answered by AI
Are new participants being sought for this clinical experiment?
"Unfortunately, this trial is not currently enrolling candidates. It was first posted on June 1st 2015 and its most recent update occurred February 13th 2015. An online search can reveal 403 clinical trials studying suicide that are actively recruiting patients as well as 105 studies examining the effects of Ketamine."
Answered by AI
Does the trial selection criteria include participants that exceed 20 years of age?
"The age criteria for this trial necessitates that candidates are more mature than 18 and less elderly than 75 years of age."
Answered by AI
Who else is applying?
What site did they apply to?
Brooke Army Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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