IV Ketamine Vs. in Esketamine for MDD TRD

This observational study (n=80) compares the acute effects of intravenous ketamine (IV ketamine) versus intranasal esketamine (IN esketamine) in treating severe depression and suicidal ideation in patients with treatment-resistant depression (MDD-TRD).

Conducted across multiple centres in Canada, including Providence Care Hospital and the Centre for Addiction and Mental Health, this study aims to gather real-world clinical data on the effectiveness and tolerability of these treatments.

Participants are adult outpatients aged 18-75 who have major depressive episodes and have not responded adequately to previous antidepressant treatments. Both IV ketamine (administered at 0.5 mg/kg) and IN esketamine (56 mg initially, increasing to 84 mg) are provided as standard-of-care, free of charge.

The study evaluates treatment outcomes using the Montgomery-Åsberg Depression Rating Scale (MADRS) to measure changes in depressive symptoms and suicidal ideation.

The primary goal is to determine the comparative effectiveness of these treatments, while secondary outcomes include assessing the tolerability and side effects.

The study is designed to follow participants for four weeks, with outcomes assessed through both per-protocol and intention-to-treat analyses.

Topic Depression Suicidality Treatment-Resistant Depression
Compound Ketamine
Country Canada
Visit trial
Status Recruiting
Results Published No
Start date 20 March 2023
End date 20 October 2026
Phase Not Applicable
Design Open
Type Observational
Generation First Second
Participants 80
Sex All
Age 18- 70
Therapy No

Trial Details

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.

NCT Number NCT06488586

Sponsors & Collaborators

Queen's University
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Data attribution

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