Ketamine Interleaved With Electroconvulsive Therapy for Depression

  • STATUS
    Recruiting
  • End date
    Dec 6, 2021
  • participants needed
    24
  • sponsor
    St Patrick's Hospital, Ireland
Updated on 27 January 2021
ketamine
depressive disorder
depressed mood
depressive episode
major depressive disorder
electroconvulsive therapy

Summary

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.

Description

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.

Details
Condition Endogenous depression, Depression, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Depressed, depressive disorder, depressed mood, miserable, depressive disorders
Treatment Ketamine, Midazolam
Clinical Study IdentifierNCT04082858
SponsorSt Patrick's Hospital, Ireland
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Depression (Adolescent) or Depression (Treatment-Resistant) or Endogenous depression or Depression (Pediatric) or Depression (Adult and Geriatric) or ...?
Do you have any of these conditions: Depression (Major/Severe) or depressed mood or Depression (Adolescent) or Depression (Pediatric) or miserable or depressive disorder or Depression or ...?
Do you have any of these conditions: depressive disorders or depressed mood or Endogenous depression or Depression (Pediatric) or Depression or miserable or Depression (Adolescent) or Dep...?
Do you have any of these conditions: Endogenous depression or Depression (Adolescent) or Depression or miserable or Depression (Adult and Geriatric) or Depression (Treatment-Resistant) or...?
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
Clear my responses

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