Ketamine As an Adjunctive Therapy for Major Depression (2)

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.

Timeline

Start

2021-09-13

Primary completion

2024-04-18

Completion

2024-08-12

Publications

• Jelovac A, McCaffrey C, Terao M, Shanahan E, Whooley E, McDonagh K, McDonogh S, Loughran O, Shackleton E, Igoe A, Thompson S, Mohamed E, Nguyen D, O'Neill C, Walsh C, McLoughlin DM. Serial Ketamine Infusions as Adjunctive Therapy to Inpatient Care for Depression: The KARMA-Dep 2 Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1216-1224. doi: 10.1001/jamapsychiatry.2025.3019.
• Jelovac A, McCaffrey C, Terao M, Shanahan E, Mohamed E, Whooley E, McDonagh K, McDonogh S, Igoe A, Loughran O, Shackleton E, O'Neill C, McLoughlin DM. Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]). BMC Psychiatry. 2023 Nov 16;23(1):850. doi: 10.1186/s12888-023-05365-9.
• McCaffrey J, Hunter A. Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial. HRB Open Res. 2023 Nov 20;6:29. doi: 10.12688/hrbopenres.13721.2. eCollection 2023.

Drugs

Indications