drugset / Trial / NCT01700829
Ketamine in the Treatment of Suicidal Depression
Phase 4
Completed
82 enrolled
New York State Psychiatric Institute
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from depression. The first drug, Ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.
Timeline
- Start
- 2012-06
- Primary completion
- 2017-01-12
- Completion
- 2017-07-31
Publications
- Hochschild A, Keilp JG, Madden SP, Burke AK, Mann JJ, Grunebaum MF. Ketamine vs midazolam: Mood improvement reduces suicidal ideation in depression. J Affect Disord. 2022 Mar 1;300:10-16. doi: 10.1016/j.jad.2021.12.055. Epub 2021 Dec 22.
- Keilp JG, Madden SP, Marver JE, Frawley A, Burke AK, Herzallah MM, Gluck M, Mann JJ, Grunebaum MF. Effects of Ketamine Versus Midazolam on Neurocognition at 24 Hours in Depressed Patients With Suicidal Ideation. J Clin Psychiatry. 2021 Nov 2;82(6):21m13921. doi: 10.4088/JCP.21m13921.
- Grunebaum MF, Mann JJ, Galfalvy HC, Gibbons RD. Computerized-Adaptive vs. Traditional Ratings of Depression and Suicidal Thoughts: An Assay Sensitivity Pilot Study in a Ketamine Clinical Trial. Front Psychiatry. 2021 Apr 7;12:602976. doi: 10.3389/fpsyt.2021.602976. eCollection 2021.
- Grunebaum MF, Galfalvy HC, Choo TH, Keilp JG, Moitra VK, Parris MS, Marver JE, Burke AK, Milak MS, Sublette ME, Oquendo MA, Mann JJ. Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial. Am J Psychiatry. 2018 Apr 1;175(4):327-335. doi: 10.1176/appi.ajp.2017.17060647. Epub 2017 Dec 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | 0.5 mg/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.02 mg/kg | Intravenous |