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IV Ketamine vs. IN Esketamine for MDD TRD
Sponsor: Gustavo Vazquez
Summary
The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations. Participants are already taking antidepressants and/or antipsychotics as part of their regular medical care for depression,
Official title: IN Esketamine and IV Ketamine: Multi-site Observational Study Assessing the Effectiveness and Tolerability of Two Novel Therapies for Treatment-resistant Depression.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2023-03-20
Completion Date
2026-10-20
Last Updated
2024-07-10
Healthy Volunteers
No
Conditions
Interventions
Low dose IV Ketamine vs. IN Esketamine
For IV ketamine treatment, ketamine is administered at 0.5mg/kg over 40 minutes. For IN esketamine treatment, esketamine is administered as a nasal spray, two sprays per nostril (56mg total) for the first treatment and three sprays per nostril (84mg) for the rest of the acute series. All treatments are administered at the academic center under the supervision of a mental health care professional. Patients are asked to come fasting at least two hours prior to treatment and to remain resting in the treatment room throughout the dosing session. Throughout each dosing session, blood pressure, oxygen levels, and onset, duration and severity of common side effects are recorded by nursing staff and/or physicians. Patients are discharged after a minimum of 30 minutes post administration, provided that the vital signs return to baseline and that the patient is calm, alert, and oriented.
Locations (1)
Providence Care Hospital
Kingston, Ontario, Canada