Ketamine as an Adjunctive Therapy for Major Depression (2)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    104
  • sponsor
    University of Dublin, Trinity College
Updated on 23 September 2021
ketamine
depression
depressive disorder
depressed mood
depressive episode

Summary

Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression. The main purpose of the trial is to assess the mood-rating score difference between ketamine and midazolam from before the first infusion to 24 hours after the final infusion, supplemented by a 95% confidence interval. There will also be a 24-week follow-up after the final infusion session.

Description

Pragmatic, randomised, controlled, parallel-group, superiority trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a depressive episode. The investigators aim to recruit up to 104 participants who will be eligible for this study and randomly allocate 52 patients to each group. Both participants and assessors will be blind to treatment allocation. Eligible consented participants will be randomly allocated in a 1:1 ratio to a four-week course of either twice-weekly ketamine or midazolam infusions. Block randomisation will be independently performed. Physical, psychotomimetic and cognitive outcomes will be monitored before, during and after infusions. During the allocated infusions and follow-up period patients will be monitored for treatment-related adverse events relating to both mental and physical health. Participants will also be followed-up for 24 weeks after the end of the initial four-week randomised treatment and assessment period, in order to identify if and when relapse occurs. During the trial, both groups will continue usual inpatient care as prescribed by their treating team.

Details
Condition mood disorder, Endogenous depression, Bipolar Disorder, Major Depressive Episode, bipolar depression, major depressive disorder, depression, bipolar, major depressive disorder, single episode
Treatment Ketamine, Midazolam
Clinical Study IdentifierNCT04939649
SponsorUniversity of Dublin, Trinity College
Last Modified on23 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old
Montgomery-sberg Depression Rating Scale (MADRS) score 20 at screening and start of the first infusion
Voluntary admission for treatment of an acute depressive episode
Meet DSM-5 criteria for a major depressive disorder or bipolar affective disorder (current episode depression). Diagnosis of a major depressive disorder or bipolar affective disorder (DSM-5) will be confirmed by the structured diagnostic Mini International Neuropsychiatric Interview (MINI; updated Version 7 for DSM-5)

Exclusion Criteria

Current involuntary admission
Medical condition rendering unfit for ketamine/midazolam
Currently taking any of the contraindicated medications that may alter the pharmacokinetics of ketamine
Active suicidal intention
Dementia
History of Axis 1 diagnosis other than major depression
Electroconvulsive Therapy (ECT) administered within the last two months
Alcohol/substance dependence in previous six-months
Pregnancy, breastfeeding or considering becoming pregnancy whilst on the trial for up to 12 weeks after last dose or inability to confirm use of adequate contraception during the trial
Breastfeeding women
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