A Study of Ketamine in Patients With Treatment-resistant Depression

Phase 2 Completed 68 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).

Timeline

Start: 2012-08-06
Primary completion: 2013-09-12
Completion: 2013-09-12

Outcome

Met primary endpoint

registry Placebo: 2 Times Per Week vs Ketamine: 2 Times Per Week; p < 0.001; Difference of Least Square Means -16.0 (70% CI -20.00 to -12.01) NCT01627782 ↗

registry Placebo: 3 Times Per Week vs Ketamine: 3 Times Per Week; p < 0.001; Difference of Least Square Means -16.4 (70% CI -18.96 to -13.84) NCT01627782 ↗

Publications

Lewis S, Romano C, De Bruecker G, Murrough JW, Shelton R, Singh JB, Jamieson C. Analysis of Clinical Trial Exit Interview Data in Patients with Treatment-Resistant Depression. Patient. 2019 Oct;12(5):527-537. doi: 10.1007/s40271-019-00369-8.
Johnson KM, Devine JM, Ho KF, Howard KA, Saretsky TL, Jamieson CA. Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response. J Clin Psychiatry. 2016 Dec;77(12):1681-1686. doi: 10.4088/JCP.15m10253.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	0.5 mg/kg	Intravenous