Comparing IV Ketamine and Esketamine for Severe Depression
IN Esketamine and IV Ketamine: Multi-site Observational Study Assessing the Effectiveness and Tolerability of Two Novel Therapies for Treatment-resistant Depression.
This study is testing whether IV ketamine or nasal esketamine works better as an extra treatment for adults with severe depression that hasn't improved with other medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06488586 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the acute effects of IV ketamine and IN esketamine in adults aged 18-75 suffering from treatment-resistant depression (MDD-TRD). Participants, who are already on antidepressants or antipsychotics, will receive either treatment as an add-on therapy, with the study collecting real-world clinical data from multiple centers across Canada. The study will monitor the effects of these treatments while ensuring that any medications that could interact with ketamine or esketamine are discontinued prior to and during the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adult outpatients aged 18-75 with unipolar depression and a history of at least two failed antidepressant treatments.
Not a fit: Patients with psychosis, personality disorders, uncontrolled hypertension, substance abuse issues, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with severe depression who have not responded to previous therapies.
How similar studies have performed: Other studies have shown promising results with ketamine and esketamine for treatment-resistant depression, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Individuals 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, were ineligible to receive IV ketamine or IN esketamine.
Where this trial is running
Kingston, Ontario
- Providence Care Hospital — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gustavo H Vazquez, MD,PhD,FRCPC — Queen's University
- Study coordinator: Gustavo H Vazquez, MD,PhD,FRCPC
- Email: g.vazquez@queensu.ca
- Phone: +1 (613)-544-4900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.