Intranasal Ketamine in Treatment-Resistant Depression

Summary

The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).

Timeline

Start

2011-10

Primary completion

2014-10

Completion

2014-10

Outcome

Met primary endpoint

paper Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t = 4.39, p < .001; PMID 24821196 ↗

registry analysis (superiority or other test); Ketamine vs Placebo; p <0.001; Mean Difference (Final Values) 7.6 (95% CI 3.9 to 11.3); Paired t-test, 2 sided NCT01304147 ↗

Publications

• Results Lapidus KA, Levitch CF, Perez AM, Brallier JW, Parides MK, Soleimani L, Feder A, Iosifescu DV, Charney DS, Murrough JW. A randomized controlled trial of intranasal ketamine in major depressive disorder. Biol Psychiatry. 2014 Dec 15;76(12):970-6. doi: 10.1016/j.biopsych.2014.03.026. Epub 2014 Apr 3.
• Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	50 mg	Intranasal

Indications