Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetamineRecruiting

ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression

Randomised, parallel-group trial (n=62) comparing high-intensity daily IV ketamine (0.50 mg/kg for 8 days; HIKER) versus ECT with ketamine anaesthesia (EAST; 8 sessions) for treatment-resistant depression.

Target Enrollment
62 participants
Study Type
Phase IV interventional
Design
Randomized, single Blind

Detailed Description

This randomised, parallel trial evaluates whether an intensive daily IV ketamine regimen with ECT rescue (HIKER) hastens remission, reduces side effects and need for ECT, and is preferred by patients compared with standard ECT with ketamine-based general anaesthesia (EAST).

HIKER participants receive IV ketamine 0.50 mg/kg on eight successive weekdays; non-responders after three treatments are switched to an eight-session course of ECT under ketamine anaesthesia. EAST participants receive eight ECT treatments with ketamine 0.75 mg/kg plus remifentanil and succinylcholine as needed. Primary outcomes focus on speed of remission and safety/tolerability.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Study Arms & Interventions

HIKER

experimental

High Intensity Ketamine (HIKER): daily IV ketamine 0.50 mg/kg for 8 successive weekdays; non-responders after 3 treatments receive rescue ECT.

Interventions

  • Ketamine0.5 mg/kg
    via IV• daily for 8 days• 8 doses total

    Single IV infusion per day; non-responders after 3 treatments switched to rescue ECT.

EAST

active comparator

ECT with ketamine-based general anaesthetic (EAST): eight ECT sessions (2–3/week) with ketamine 0.75 mg/kg plus remifentanil and succinylcholine as needed.

Interventions

  • Ketamine0.75 mg/kg
    via IV• per ECT session• 8 doses total

    Ketamine as primary anaesthetic

  • Compound1 µg/kg
    via IV• per ECT session

    Remifentanil (1 µg/kg) to reduce discomfort; dose titrated by anaesthesiologist

  • Compound0.75 mg/kg
    via IV• per ECT session

    Succinylcholine 0.75 mg/kg for safety; anaesthesiologist may vary doses or add propofol as needed

  • Compound
    via Other

    ECT procedure: unilateral or bilateral electrode placement with seizure threshold monitored by half-age method

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Montgomery Asberg Depression Rating Scale (MADRS) score greater than 20; planned for ECT therapy.
  • Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration.

Exclusion Criteria

  • Subjects ineligible if they cannot provide informed consent.
  • American Society of Anesthesiology physical status score of four or greater.
  • Implanted electronic medical device (e.g., pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, deep brain stimulator).
  • Schizoaffective disorder.
  • Women of child-bearing potential who refuse or screen positive on pregnancy test.
  • Allergy to any study drug or carrier components.
  • Any serious physical condition prior to randomization deemed by the attending psychiatrist or consulting anesthetist to be a contraindication to ECT (including cardiovascular disease, untreated hypertension, respiratory disease, cerebrovascular disease, intracranial hypertension including glaucoma, or seizures).

Study Details

Locations

Royal University Hospital — Saskatoon, Saskatchewan, Canada

Your Library