IV Ketamine + Propofol-ECT for Treatment-Resistant Depression: Pilot fMRI Study (Zhang 2020, Tianjin Anding Hospital)
Single-arm within-subject pilot (Psychiatry Research 2020; Zhang J et al.; Tianjin Anding Hospital; DOI 10.1016/j.psychres.2020.112907). Enrolled Dec 2014 – Dec 2018. Participants: n=28 right-handed adults with TRD who had failed to respond to ≥12 sessions of propofol-ECT in the prior 2 months. No control arm, no randomisation. Intervention: 6 × IV ketamine (0.5 mg/kg over 40–50 min, at 22:00) + 6 × bilateral ECT with propofol (1–2 mg/kg) anaesthesia the following morning; delivered three times/week for 2 weeks. Resting-state fMRI (3T GE) at baseline and days 1/3/7/10/14. HAMD-17 at baseline, day 7, day 14. Primary metrics: global functional connectivity density (gFCD) and DMN functional connectivity strength (FCS). IRB-approved (Tianjin Anding Hospital ethics committee). CT.gov: 0 hits; PubMed DataBankList: empty; CrossRef: no clinical-trial-number.
Study Arms & Interventions
Ketamine plus propofol-ECT
experimentalPatients received intravenous ketamine and propofol-electroconvulsive therapy (ECT) alternately.
Interventions
- Ketamine0.5 mg/kgvia IV• six times within 14 days• 6 doses total
Injected at 10:00 pm the day before propofol-ECT
- Placebo1 mg/kgvia IV• six times within 14 days• 6 doses total
Used as anaesthetic during ECT; dose range 1-2 mg/kg
- Placebovia null• six times within 14 days• 6 doses total
Bilateral ECT; stimulus intensity adjusted by energy percentage
Propofol-ECT
active comparatorPatients received propofol-electroconvulsive therapy (ECT) only.
Interventions
- Placebo1 mg/kgvia IV• six times within 14 days• 6 doses total
Used as anaesthetic during ECT; dose range 1-2 mg/kg
- Placebovia null• six times within 14 days• 6 doses total
Bilateral ECT
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine plus propofol-ECTexperimental | 28 | — | — | — | — |
| Propofol-ECTactive_comparator | — | — | — | — | — |
* This pilot study focused on antidepressant effects and brain functional alterations. While general safety concerns related to ketamine (e.g., cardiovascular effects, neurocognitive, urologic toxicity, addiction tendency, tolerance) are discussed by referencing other literature, no specific adverse event counts (total, severe, serious, discontinuations, or special interest) for the 28 participants in this study were reported.
* The paper describes a single-arm pilot study of 28 patients receiving 'Ketamine plus propofol-ECT'. The 'Propofol-ECT' arm was not part of this specific trial; comparisons were made to a 'propofol-ECT treatment group' which appears to be a historical or external reference, not a concurrently enrolled arm with reported safety data in this paper.