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RECRUITING
NCT06488586

IV Ketamine vs. IN Esketamine for MDD TRD

Sponsor: Gustavo Vazquez

View on ClinicalTrials.gov

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

Interventions

DRUG

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