Ketamine Versus Midazolam for Depression Relapse Prevention Following Successful Electroconvulsive Therapy: A...

Area of Science:

• Neuroscience
• Psychiatry
• Clinical Trials

Background:

• Depression relapse is common after electroconvulsive therapy (ECT), occurring in 40% of patients within 6 months.
• Ketamine shows antidepressant effects, but its use in preventing ECT-related depression relapse has not been studied.
• This pilot trial (NCT02414932) aimed to assess the feasibility of a trial protocol for ketamine in depression relapse prevention.

Purpose of the Study:

• To evaluate the feasibility of a clinical trial protocol for ketamine in preventing depression relapse post-ECT.
• To identify reasons for challenges in recruitment, randomization, and participant dropout.
• To inform the design of future clinical trials investigating intravenous ketamine for depression relapse.

Main Methods:

• Patients with unipolar depression undergoing ECT were monitored for response using the Hamilton Rating Scale for Depression.
• Eligible responders were invited to a randomized phase comparing ketamine infusions to midazolam.
• Participants were followed for 6 months to assess relapse rates.

Main Results:

• Only 68% of eligible patients were recruited to the monitoring phase, and 26% of responders consented to the treatment phase.
• All 6 randomized participants (3 ketamine, 3 midazolam) dropped out before completing the 4-week treatment.
• Reasons for dropout included practical issues with infusions and lack of interest post-ECT response.

Conclusions:

• The proposed treatment protocol is not suitable for a definitive trial at this center.
• Findings highlight significant challenges in implementing intravenous ketamine trials for depression relapse prevention.
• Information on dropout reasons can guide future trial designs in this area.