IM Ketamine vs Oral Ketamine vs ECT in Major Depressive Disorder with Suicidal Ideation: A Randomised Pilot Study (Kheirabadi 2020, Isfahan)
Randomised, open-label, parallel-group pilot study (J Clin Psychopharmacol 2020; Kheirabadi D, Kheirabadi GR, Mirlohi Z, Tarraji MJ, Norbaksh A; Isfahan University of Medical Sciences, Isfahan, Iran). Participants: 45 adults with DSM-5 MDD aged 18–70 years who were suitable candidates for ECT (severe or suicidal or treatment-refractory presentation). Three equal groups (n=15 each): (1) intramuscular (IM) ketamine 0.5 mg/kg; (2) oral ketamine 1 mg/kg; (3) electroconvulsive therapy (ECT), 6–9 sessions over 3 weeks. Depression assessed with Hamilton Depression Rating Scale (HDRS); suicidal ideation scored separately. Registration: stated in paper as registered in the Iranian Registry of Clinical Trials (IRCT); specific IRCT number not recoverable (CT.gov: 0 hits; IRCT.ir connection timeout). Synthetic trial entry created from abstract metadata.
Study Arms & Interventions
ECT
active comparatorElectroconvulsive 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
experimental0.5 mg/kg of intramuscular (IM) racemic ketamine repeated for 6 to 9 injections during 3 weeks.
Interventions
- Ketamine0.5 mg/kgvia 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
experimental1 mg/kg of oral R-ketamine every 2 to 3 days up to 6 to 9 sessions during 3 weeks.
Interventions
- Ketamine1 mg/kgvia 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.
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| ECTactive_comparator | 12 | — | — | — | — |
| IM Ketamineexperimental | 15 | — | — | — | — |
| Oral Ketamineexperimental | 12 | — | — | — | — |
* The paper mentions complications including headache, nausea, musculoskeletal pain, and memory deficiency (which could last up to 1 month in 58.3% of patients), but does not provide summary counts for TEAEs in the main text or tables.
* The paper mentions most significant complications included dissociative symptoms and nystagmus, which lasted no more than 4 hours, but does not provide summary counts.