drugset / Trial / NCT00419003
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Phase 4
Completed
26 enrolled
Baylor College of Medicine
National Alliance for Research on Schizophrenia and Depression · collabNational Center for Research Resources (NCRR) · collab
RandomizedFactorialTriple-blindTreatment
Summary
This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
Timeline
- Start
- 2006-12
- Primary completion
- 2008-07
- Completion
- 2008-09
Outcome
Missed primary endpoint
paper An interim analysis found no significant differences in time-to-relapse between riluzole and placebo groups [log-rank chi(2) = 0.17, d.f. = 1, p = 0.68] PMID 19288975 ↗
paper Riluzole did not prevent relapse in the first month following ketamine. PMID 19288975 ↗
Publications
- Wan LB, Levitch CF, Perez AM, Brallier JW, Iosifescu DV, Chang LC, Foulkes A, Mathew SJ, Charney DS, Murrough JW. Ketamine safety and tolerability in clinical trials for treatment-resistant depression. J Clin Psychiatry. 2015 Mar;76(3):247-52. doi: 10.4088/JCP.13m08852.
- Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.
- Mathew SJ, Murrough JW, aan het Rot M, Collins KA, Reich DL, Charney DS. Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial. Int J Neuropsychopharmacol. 2010 Feb;13(1):71-82. doi: 10.1017/S1461145709000169. Epub 2009 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | Lamotrigine | Small molecule | 300 mg | — |
| Subject | Riluzole | Small molecule | 100 mg | Oral |
| Subject | Riluzole | Small molecule | 200 mg | Oral |