Suicidal Ideation study: Ketamine hydrochloride
Official title Understanding and Treating Suicidal Ideation With Ketamine
ClinicalTrials.gov ID: NCT06891300
What this study is testing
What is Ketamine Hydrochloride?
An investigational intravenous medicine being studied for reducing suicidal ideation in people with major depressive disorder.
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 study wants to see if ketamine reduces suicidal thoughts and if brain changes seen on MRI match those changes.
- Who it's for
- Adults who have major depression and are currently thinking about suicide.
- What's involved
- Participants will get four IV ketamine shots, two each week for two weeks, and will have brain scans and questionnaires before and after the treatment, plus an interview after the last shot.
- Time commitment
- The study lasts about two weeks, with four ketamine visits, two MRI scans, several questionnaires, and one interview.
- 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 65
You may be able to join if
- English speaking
- Ages 18-65 years old
- Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit ("active...
- Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)
- Willing to maintain stable doses of concomitant medications throughout the study
You likely can't join if
- Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension...
- Known or suspected hypersensitivity or intolerance to ketamine
- Body mass index (BMI) ≥35
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or...
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
See the full eligibility criteria
- English speaking
- Ages 18-65 years old
- Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit ("active suicidal ideation with any methods")
- Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)
- Willing to maintain stable doses of concomitant medications throughout the study
- Be under the care of a designated health care provider (i.e., family physician or psychiatrist) to follow their care after the completion of the study.
- Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease...
- Known or suspected hypersensitivity or intolerance to ketamine
- Body mass index (BMI) ≥35
- History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\<2 years) acute episode of psychosis
- Current and/or recent history (\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria
- Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study
- History of significant head injury including loss of consciousness \>5 minutes
- Any MRI contraindications
- Concurrent use of ketamine in any form
- Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.