Clinical TrialMajor Depressive Disorder (MDD)PlaceboKetamineKetamineCompleted

IM Ketamine vs Oral Ketamine vs ECT in Major Depressive Disorder with Suicidal Ideation: A Randomised Pilot Study (Kheirabadi 2020, Isfahan)

This unregistered trial (n=45) was a randomised, open-label pilot study of intramuscular or oral ketamine versus electroconvulsive therapy for major depressive disorder with suicidal ideation in adults, which found ketamine to be as effective as ECT with higher patient preference.

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Target Enrollment
45 participants
Study Type
interventional
Design
Randomized

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study compared the antidepressant and antisuicidal effects of three different treatment modalities: intramuscular (IM) racemic ketamine at 0.5 mg/kg, oral R-ketamine at 1 mg/kg, and electroconvulsive therapy (ECT) consisting of 6 to 9 sessions over three weeks. The participants were 45 adults aged 18 to 70 years diagnosed with major depressive disorder (MDD) who were considered suitable candidates for ECT due to the severity of their symptoms or suicidal ideation.

Results indicated that all three interventions significantly improved depression and suicidal ideation scores compared to baseline, with no significant differences in efficacy between the groups. However, the ketamine groups experienced only transient dissociative symptoms, whereas some patients in the ECT group experienced memory loss for up to one month. Ultimately, patients reported higher satisfaction and preference for the ketamine-based treatments.

Study Arms & Interventions

ECT

active comparator

Electroconvulsive therapy (ECT) consisting of 6 to 9 sessions during 3 weeks.

Interventions

  • Placebo
    • 6 to 9 sessions during 3 weeks

    Electrical stimulus titrated based on duration of induced seizure; electrodes placed bifrontotemporal.

IM Ketamine

experimental

0.5 mg/kg of intramuscular (IM) racemic ketamine repeated for 6 to 9 injections during 3 weeks.

Interventions

  • Ketamine0.5 mg/kg
    via IM• 6 to 9 injections during 3 weeks (with a 2- to 3-day interval)• 9 doses total

    Racemic ketamine (R-ketamine) administered in gluteus medius site.

Oral Ketamine

experimental

1 mg/kg of oral R-ketamine every 2 to 3 days up to 6 to 9 sessions during 3 weeks.

Interventions

  • Ketamine1 mg/kg
    via Oral• every 2 to 3 days up to 6 to 9 sessions during 3 weeks• 9 doses total

    R-ketamine administered with flavors and sweeteners to eliminate bitter taste.

Study Details

Locations

Iran

Related Publications

PaywallindividualPrimary

Comparison of Rapid Antidepressant and Antisuicidal Effects of Intramuscular Ketamine, Oral Ketamine, and Electroconvulsive Therapy in Patients With Major Depressive Disorder

In a randomised pilot trial of 45 ECT‑candidate patients with major depressive disorder, intramuscular and oral ketamine produced rapid antidepressant and antisuicidal effects comparable to electroconvulsive therapy. Ketamine's adverse effects were brief and transient (mainly dissociative), whereas some ECT patients experienced memory loss up to one month and patients reported greater satisfaction with ketamine, suggesting it as a viable alternative for severe or suicidal MDD.

Published
Journal
Journal of Clinical Psychopharmacology
Authors
Kheirabadi, D., Kheirabadi, G. R., Mirlohi, Z., Tarrahi, M. J., Norbaksh, A.