Ketamine vs Esketamine for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare the effects of two treatments, ketamine and esketamine, for individuals with severe depression who have not responded to at least two different antidepressants. Participants will continue their current medications for depression or related conditions. The study examines how these treatments impact depression and suicidal thoughts. It suits adults diagnosed with major depressive disorder who have tried multiple antidepressants without success. Individuals with certain other conditions or who have previously had negative reactions to these treatments should not participate. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since participants are already taking antidepressants and/or antipsychotics, it seems likely that you can continue your current treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that IV ketamine was well-tolerated by people with treatment-resistant depression. Most patients handled the treatment well, though some experienced mild side effects like temporary dizziness or nausea. This indicates that people managed the treatment without major problems.
Research has shown that using esketamine as a nasal spray is also safe. Long-term studies have confirmed its safety over time, with no new safety issues. Some people might feel slightly dizzy or get a headache after using it, but these effects are usually mild and short-lived.
Both treatments have proven to be safe options for managing severe depression in people who haven't responded to other treatments.12345Why are researchers excited about this trial?
Researchers are excited about using IV ketamine and IN esketamine for treating major depressive disorder with treatment-resistant depression (MDD TRD) because these treatments offer a new approach compared to traditional antidepressants. Unlike standard options, which often involve oral medications affecting serotonin, norepinephrine, or dopamine levels, ketamine and esketamine work differently by targeting the brain's NMDA receptors. This unique mechanism can lead to rapid antidepressant effects, potentially providing relief in just hours or days instead of weeks. Additionally, esketamine's intranasal delivery method offers a convenient alternative to intravenous administration, making it more accessible for some patients.
What evidence suggests that this trial's treatments could be effective for severe depression and suicidal ideations?
This trial will evaluate the effects of IV ketamine and IN esketamine as standard-of-care, add-on treatments for adult outpatients with treatment-resistant depression (TRD). Studies have shown that both IV ketamine and IN esketamine can quickly benefit individuals with TRD. Specifically, research indicates that a single IV ketamine infusion can rapidly ease depression symptoms, often within one day, and has been linked to significant improvements in depression and suicidal thoughts. Similarly, IN esketamine has improved depression symptoms and works well both alone and in combination with other treatments. Known for its fast effects, some patients feel better just hours after use. Both treatments offer promising options for those who haven't found relief with traditional antidepressants.36789
Who Is on the Research Team?
Gustavo H Vazquez, MD,PhD,FRCPC
Principal Investigator
Queen's University
Are You a Good Fit for This Trial?
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IV ketamine or IN esketamine treatment bi-weekly for four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IN Esketamine
- IV Ketamine
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants consisted of adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD, diagnosed with major depressive disorder as outlined by the DSM5 and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode. IV ketamine or IN esketamine are provided as standard-of-care, add-on treatments. Benzodiazepines, naltrexone, lamotrigine, gabapentin and pregabalin, are discontinued prior to the start of the treatment and for the duration of treatment. Patients with psychosis, main diagnosis of personality disorder, uncontrolled hypertension, substance abuse, currently pregnant or breastfeeding, or who had a previous negative reaction to ketamine or esketamine, are ineligible to receive IV ketamine or IN esketamine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gustavo Vazquez
Lead Sponsor
Gustavo Vazquez
Lead Sponsor
Centre for Addiction and Mental Health
Collaborator
Envision Mind Care
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Djavad Mowafaghian Centre for Brain Health
Collaborator
Citations
Data from REAL-ESK Study Group
Conclusion: The results support the effectiveness and safety of esketamine in the mid and long-term treatment of TRD patients. The late clinical response of a ...
Esketamine Monotherapy in Adults With Treatment ...
These findings support esketamine as a monotherapy option for patients with TRD, especially for those experiencing treatment-limiting tolerability concerns.
Treatment-resistant depression and intranasal esketamine
Retrospective studies showed intranasal esketamine improved symptoms of depression and achieved a response in patients with post-traumatic stress disorder.
Intranasal Esketamine (SpravatoTM) for Use in Treatment ...
The MADRS score at four hours post-dose improved significantly in IN-esketamine patients compared with placebo patients (least squares mean [SE] difference vs.
2023-5354 - The YODA Project
The primary outcome measure will be the Montgomery-Åsberg Depression Rating Scale (MADRS) scores prior to and throughout treatment with intranasal esketamine.
Safety and efficacy with esketamine in treatment-resistant ...
To evaluate the long-term safety and efficacy of esketamine nasal spray, combined with an oral antidepressant, in patients with TRD.
Benefits and risks of esketamine nasal spray continuation ...
Intranasal esketamine is effective for short-term and long-term treatment of adult TRD. Intranasal esketamine has an established safety profile for long-term ...
Safety and efficacy with esketamine in treatment-resistant ...
In the SUSTAIN-3 final dataset, no new safety signals were identified during long-term treatment with intermittently-dosed esketamine, combined with oral ...
interim results of the SUSTAIN-3 study
The approvals of esketamine nasal spray were based on efficacy and safety findings from phase 2/3 studies of TRD treatment for 4 weeks to 1 year ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.