Ketamine as an Adjunctive Therapy for Major Depression (2)

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dublin, Trinity College
• Treatments: Ketamine; Midazolam

Criteria

Inclusion Criteria:

• ≥18 years old.

• Montgomery-Åsberg 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.