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NMDA Antagonist

Ketamine for Suicide Attempts

Phase 3
Recruiting
Led By Tatiana Falcone, M.D.
Research Sponsored by Tatiana Falcone, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be 14 to 30 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months post-discharge
Awards & highlights

Study Summary

This trial is testing whether ketamine can help decrease suicidal ideation in young people who have attempted suicide.

Who is the study for?
This trial is for young individuals aged 14-30 who have attempted suicide and are currently experiencing suicidal thoughts. They must understand the study and agree to participate. Exclusions include those with certain mental health conditions, intellectual disabilities, recent drug abuse, or specific medical contraindications.Check my eligibility
What is being tested?
The trial tests Ketamine's ability to reduce suicidal thoughts in youth after a suicide attempt. Participants will receive either Ketamine or saline while hospitalized and undergo CAMS Therapy weekly during and after hospitalization until they show significant improvement in their condition.See study design
What are the potential side effects?
Ketamine may cause side effects such as disorientation, dizziness, nausea, increased blood pressure, abnormal heart rhythms, hallucinations or changes in mood. The severity of these effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 14 and 30 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Suicide
Secondary outcome measures
Change of Beck Scale for Suicide Ideation score will be analyzed
Number of CAMS sessions needed to achieve enduring mental state

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine Treatment + CAMS TherapyExperimental Treatment2 Interventions
Group II: Saline Placebo Treatment + CAMS TherapyPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~910

Find a Location

Who is running the clinical trial?

Tatiana Falcone, MDLead Sponsor
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,439 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,009 Total Patients Enrolled
5 Trials studying Suicide Attempt
28,921 Patients Enrolled for Suicide Attempt

Media Library

Ketamine Hydrochloride (NMDA Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04763343 — Phase 3
Suicide Attempt Research Study Groups: Ketamine Treatment + CAMS Therapy, Saline Placebo Treatment + CAMS Therapy
Ketamine Hydrochloride (NMDA Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763343 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you list other research that has used Ketamine Hydrochloride?

"The first study using ketamine hydrochloride was completed in 2013 at Cedars Sinai Medical Center. Since then, a total of 844 clinical trials have been completed. Currently, 115 clinical trials are ongoing, with a significant number of these trials taking place in Cleveland, Ohio."

Answered by AI

Has Ketamine Hydrochloride received formal backing from the FDA?

"There is some clinical evidence to support the safety of Ketamine Hydrochloride, and because this is a Phase 3 trial, it received a score of 3."

Answered by AI

Will this test be conducted on individuals who are octogenarians?

"Eligibility for this particular study is limited to those aged 15-24. Out of the 301 total clinical trials, 74 are for patients under 18 years old and 209 are for patients over 65."

Answered by AI

Do I meet the prerequisites to join this clinical trial?

"This study is open to 140 participants who are currently experiencing parasuicide and meet the following criteria: Subjects must be 15 to 24 years of age, Subjects must have been admitted to the hospital inpatient unit after a suicide attempt (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was indicated) and continued to express suicidal ideation. Also at time of screening clinician rated Scale for Suicidal Ideation (SSI) score should be ≥6., Subjects must have the ability to understand and the willingness to sign a written informed consent document."

Answered by AI

What is the desired number of participants for this trial?

"That is correct. The clinical trial in question is still looking for patients, as seen on clinicaltrials.gov. The study was first posted on 6/27/2022 and was most recently updated on 8/1/2022. They are aiming to enroll 140 patients total at 2 different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am very interested in learning more about ketamine and its health benefits to help curb depression and suicidal tendencies. I have attempted suicide three times and hate feeling lost and sad.
PatientReceived 2+ prior treatments
~6 spots leftby Jun 2024