CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04939649
NCT04939649Phase 3Completed
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Ketamine As an Adjunctive Therapy for Major Depression - a Randomised Controlled Trial: [KARMA-Dep (2)]

University of Dublin, Trinity College·interventional·Posted Jun 25, 2021·Updated Feb 13, 2025

In Brief

A Phase 3 clinical trial evaluating Ketamine and Midazolam for Major Depressive Episode and 2 related conditions. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Episode, Unipolar Depression, Bipolar Depression
CountriesIreland
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 25, 2021
Enrollment StartSep 13, 2021
Primary CompletionApr 18, 2024
Study CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.0 years ago

Interventions

Ketaminedrug

A sub-anaesthetic dose of ketamine will be administered for up to a four-week course of twice-weekly infusions.

Midazolamdrug

A sub-anaesthetic dose of midazolam will be administered for up to a four-week course of twice-weekly infusions.