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New treatment option for Suicide, Attempted
Official title Ketamine Treatment of Youth Suicide Attempters
ClinicalTrials.gov ID: NCT04763343
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for suicide, attempted.
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
- Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 14 to 30
You may be able to join if
- people must be 14 to 30 years of age
- people must have been admitted to Cleveland Clinic Hospital (Fairview or Lutheran Hospital) after a suicide attempt (any intentional, non-fatal self-...
- people must have the ability to understand and the willingness to sign a written informed consent document.
You likely can't join if
- people with known history of autistic spectrum disorder; non-verbal patients.
- people with moderate or severe intellectual disability (IQ less than 70 and those patients in special education full-time).
- people with schizophrenia or history of any type of psychosis including mood disorder related psychosis and brief reactive psychosis.
- Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (people prescribed amphetamines for...
- people with history of moderate or severe substance or alcohol use per DSM- V criteria in the past 6 months.
- people with any contraindication to ketamine such as allergic reaction to ketamine or medical or neurological condition with a contraindication for...
See the full eligibility criteria
- people must be 14 to 30 years of age
- people must have been admitted to Cleveland Clinic Hospital (Fairview or Lutheran Hospital) after a suicide attempt (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was...
- people must have the ability to understand and the willingness to sign a written informed consent document.
- people with known history of autistic spectrum disorder; non-verbal patients.
- people with moderate or severe intellectual disability (IQ less than 70 and those patients in special education full-time).
- people with schizophrenia or history of any type of psychosis including mood disorder related psychosis and brief reactive psychosis.
- Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (people prescribed amphetamines for management of ADHD will not be excluded)
- people with history of moderate or severe substance or alcohol use per DSM- V criteria in the past 6 months.
- people with any contraindication to ketamine such as allergic reaction to ketamine or medical or neurological condition with a contraindication for use of ketamine or on any drugs associated with significant interaction...
- people who are currently pregnant and/or breast feeding.
- people with previous recreational ketamine use. people with previous therapeutic Ketamine use that exceeds the maximum cumulative lifetime exposure of 60 mg daily and 8 administrations maximum (or 480 mg) during both...
- people with hypertension, history of myocardial infarction, congestive heart failure of Stage 2 or higher, angina, or QTcF of at least 450 msec as indicated by chart review and/or standard of care EKG performed upon...
- people in the custody of Children's Services.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
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, 14 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, 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.