Trial | NCT04082858  Report issue

Title

Ketamine Interleaved With Electroconvulsive Therapy for Depression
Ketamine Interleaved With Electroconvulsive Therapy for Depression, A Pragmatic Randomised Controlled Pilot Trial

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    3
Pragmatic, randomised, controlled, parallel group, pilot clinical trial of ketamine vs. midazolam interleaved with electroconvulsive therapy (ECT) as an adjunctive treatment for a major depressive episode. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.
Patients referred for treatment with ECT at St Patrick's Mental Health Services for treatment of a depressive episode will be eligible for recruitment to the clinical trial. Participants will be invited to be randomised to a course of twice-weekly ketamine or midazolam infusions for the duration of ECT. Participants will receive the first allocated infusion following the first or second treatment with ECT. Block randomisation will be independently performed. Infusions will be delivered on separate days to ECT. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions.Treatment-as-usual will continue throughout the entire trial.

Trial Interventions: participants will receive twice-weekly infusions of either ketamine at 0.5mg/Kg or midazolam at 0.045mg/Kg. All infusions will be administered by a Consultant Anaesthetist. Repeated infusions of allocated drug have been shown to be safe and well tolerated by patients with mental illness. Minor haemodynamic changes and psychotomimetic side effects can occur and will be assessed regularly during infusions and for 120 minutes afterwards. Participants will be followed-up at six weeks and three months after the final infusion to assess for relapse according to standardised criteria.
Study Started
Jan 06
2020
Primary Completion
Jun 03
2020
Study Completion
Jun 03
2020
Last Update
Sep 09
2021

Drug Ketamine

A sub-anaesthetic dose of ketamine will be administered in twice-weekly infusions

  • Other names: Ketalar

Drug Midazolam

A sub-anaesthetic dose of midazolam will be administered in twice-weekly infusions

  • Other names: Hyponovel

Ketamine Experimental

Participants will receive twice-weekly infusions of ketamine at 0.05mg/kg for the duration of treatment with ECT. All infusions will be administered by a Consultant Anaesthetist.

Midazolam Active Comparator

Participants will receive twice-weekly infusions of midazolam at 0.045mg/kg for the duration of treatment with ECT. All infusions will be administered by a Consultant Anaesthetist.

Criteria 

Inclusion Criteria:

≥18 years old
Able to provide informed consent
Voluntary admission for treatment of an acute depressive episode
Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of ≥20
Referred for treatment with ECT
Sufficiently physically healthy to receive ketamine/midazolam and ECT

Exclusion Criteria:

Inability to provide informed consent
Current involuntary admission
History of Axis 1 diagnosis other than major depression
Medical condition rendering unfit for ECT
Active suicidal intention
Presence of major neurological or organic brain disorder
Alcohol/substance dependence in previous six-months
Pregnancy or inability to confirm use of adequate contraception during the trial
Breastfeeding women
Contraindications to ketamine
Contraindications to midazolam
No Results Posted