Ketamine As an Adjunctive Therapy for Major Depression (2)

Last updated: February 10, 2025
Sponsor: University of Dublin, Trinity College
Overall Status: Completed

Phase

3

Condition

Depression (Major/severe)

Depression (Treatment-resistant)

Bipolar Disorder

Treatment

Ketamine

Midazolam

Clinical Study ID

NCT04939649
CRFSPN004
2019-003109-92
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old.

  • Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 20 at screening and startof 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 bipolaraffective disorder (DSM-5) will be confirmed by the structured diagnostic MiniInternational Neuropsychiatric Interview (MINI; updated Version 7 for DSM-5).

Exclusion

Exclusion Criteria:

  • Current involuntary admission.

  • Medical condition rendering unfit for ketamine/midazolam.

  • Currently taking any of the contraindicated medications that may alter thepharmacokinetics of ketamine.

  • Active suicidal intention.

  • Dementia.

  • Lifetime history of schizophrenia or schizoaffective disorder; active anorexianervosa or bulimia nervosa in the past 12 months; alcohol or other substance usedisorder (with the exception of nicotine) in the previous six months; any DSM-5disorder other than a major depressive episode (unipolar or bipolar) as the primarypresenting problem.

  • Electroconvulsive Therapy (ECT) administered within the last two months.

  • Pregnancy, breastfeeding or considering becoming pregnancy whilst on the trial forup to 12 weeks after last dose or inability to confirm use of adequate contraceptionduring the trial.

  • Breastfeeding women.

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: Ketamine
Phase: 3
Study Start date:
September 13, 2021
Estimated Completion Date:
August 12, 2024

Study Description

Pragmatic, randomised, controlled, parallel-group, superiority trial. Trial participants will be patients admitted to St Patrick's University Hospital for treatment of a major 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 course of up to eight infusions of either ketamine or midazolam twice weekly over up to four weeks. 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 randomised treatment and assessment period lasting up to four weeks, 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.

Connect with a study center

  • St Patrick's Univeristy Hospital

    Dublin, D8
    Ireland

    Site Not Available

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