Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboPlaceboPlaceboPlaceboCompleted

IV Ketamine + Propofol-ECT for Treatment-Resistant Depression: Pilot fMRI Study (Zhang 2020, Tianjin Anding Hospital)

This unregistered trial (n=28) was a pilot study of intravenous ketamine combined with propofol-electroconvulsive therapy for treatment-resistant depression in adults, finding that the combination improved antidepressant effects for approximately seven days.

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Target Enrollment
28 participants
Study Type
Phase II interventional
Design
Non-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 investigated the efficacy of combining intravenous ketamine with propofol-electroconvulsive therapy (ECT) in patients with depression that had proven resistant to standard ECT. The intervention involved six doses of ketamine and six sessions of bilateral ECT administered over a two-week period.

Results indicated that the addition of ketamine improved antidepressant outcomes compared to ECT alone. Neuroimaging via resting-state fMRI showed increased global functional connectivity density in the left temporal and subgenual anterior cingulate cortex, alongside decreased functional connectivity strength within the default mode network. While functional brain alterations persisted for ten days, the clinical antidepressant effect was observed to last for seven days.

Study Arms & Interventions

Ketamine plus propofol-ECT

experimental

Patients received intravenous ketamine and propofol-electroconvulsive therapy (ECT) alternately.

Interventions

  • Ketamine0.5 mg/kg
    via IV• six times within 14 days• 6 doses total

    Injected at 10:00 pm the day before propofol-ECT

  • Placebo1 mg/kg
    via IV• six times within 14 days• 6 doses total

    Used as anaesthetic during ECT; dose range 1-2 mg/kg

  • Placebo
    via null• six times within 14 days• 6 doses total

    Bilateral ECT; stimulus intensity adjusted by energy percentage

Propofol-ECT

active comparator

Patients received propofol-electroconvulsive therapy (ECT) only.

Interventions

  • Placebo1 mg/kg
    via IV• six times within 14 days• 6 doses total

    Used as anaesthetic during ECT; dose range 1-2 mg/kg

  • Placebo
    via null• six times within 14 days• 6 doses total

    Bilateral ECT

Study Details

Locations

China

Related Publications

Open AccessindividualPrimary

Ketamine plus propofol-electroconvulsive therapy (ECT) transiently improves the antidepressant effects and the associated brain functional alterations in patients with propofol-ECT-resistant depression

This open-label study (n=28) investigated whether ketamine (35mg/70kg) treatment prior to propofol-assisted electroconvulsive therapy (ECT) can improve clinical symptoms of depression. The addition of ketamine improved treatment, and this was accompanied by increased global functional connectivity density in the left temporal and subgenual anterior cingulated cortex and decreased functional connectivity strength within the default mode network for a period of 10 days. However, the remission of depressive symptoms only lasted 7 days.

Published
Journal
Psychiatry Research
Authors
Zhang, J., Tian, H., Li, J., Ji, S., Chen, S., Zhu, J., Jiang, D., Wang, L., Li, G., Chen, M., Wang, W., Lin, X., Zhuo, C.