i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
Recruiting · Toronto, Ontario
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Most need no insurance or papers
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Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life. There is an urgent need for new scalable treatments that can effectively reduce suicidality in people with depression. Cognitive behavioural therapy (CBT) reduces suicidal thoughts and behaviours, and can be delivered through the internet (i-CBT) making it more accessible and scalable. However, i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours (suicidality), such as within 24 hours. IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide, but not suicidal behaviours. Therefore, combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment. The investigators propose a 13-week, multi-site, study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts and/or behaviours, but have not responded to previous treatment. All 110 participants will receive a weekly session of i-CBT for 13 weeks, but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments (control treatment) over the first initial 30 days. The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint (i.e.,day 30), and after 3 months (i.e. Day 91) of the starting treatment.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults who are male or female between 21 and 65 years old (inclusive).
- •People diagnosed with Major Depressive Disorder and a current major depressive episode (MDE) without psychotic features.
- •People with a moderate to severe depressive episode, as shown by a MADRS score greater than 21.
- •People at risk for suicide, based on answers on the C-SSRS (Suicidal Ideation and/or Suicidal Behaviour subscales).
- •People who have not responded to two or more adequate first-line depression treatment trials, per the CANMAT Depression Guidelines (2016).
🚫 You may not be able to join if…
- •People with symptoms of mania or hypomania or mixed bipolar symptoms (YMRS score greater than 12).
- •People with current psychosis or a substance use disorder within the past 3 months.
- •People with a lifetime primary psychotic disorder (for example, schizophrenia or schizoaffective disorder).
- •People with a lifetime history of ketamine use disorder.
- •Pregnant or breastfeeding women (or anyone planning to become pregnant).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 21–65
- ✓Have Depression
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure, Kidney disease, Anxiety
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06480500 · Locations: Ontario