Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial...

Area of Science:

• Psychiatry
• Clinical Pharmacology
• Health Economics

Background:

• Depression is a leading global cause of disability with limited conventional antidepressant efficacy.
• Current treatments like monoaminergic antidepressants have slow onset and limited effectiveness.
• While ketamine shows rapid antidepressant effects, they are transient, necessitating research into prolonged administration methods.

Purpose of the Study:

• To evaluate the efficacy and safety of serial ketamine infusions compared to an active comparator (midazolam) for major depressive episodes.
• To provide data on response, remission, and relapse rates.
• To assess the safety, tolerability, quality of life, and cost-effectiveness of repeated ketamine infusions.

Main Methods:

• A pragmatic, randomized, controlled, patient- and rater-blind, superiority trial involving adult inpatients with major depressive episodes.
• Participants receive up to eight infusions of ketamine or midazolam twice-weekly over four weeks.
• Primary outcome is the difference in Montgomery-Åsberg Depression Rating Scale scores from baseline to 24 hours post-final infusion; 24-week follow-up monitors relapse.

Main Results:

• The trial is ongoing, and results are not yet available.
• Efficacy will be determined by comparing depression rating scale scores between ketamine and midazolam groups.
• Safety and tolerability will be assessed through monitoring of psychotomimetic, cognitive, and physical side effects.

Conclusions:

• This study aims to address the unmet clinical need for rapidly-acting antidepressants.
• Findings will inform clinical practice regarding the role of serial ketamine infusions in managing depression.
• The trial will provide crucial efficacy, safety, and health economic data.