Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results were published in JAMA Psychiatry on December 27, 2017.
The trial enrolled 126 patients diagnosed with major depressive disorder; 67 patients were randomized, and 60 completed the 2-week double-blind portion of the study. Patients continued to receive standard of care treatment, which consisted of oral antidepressants, throughout the study period.
The study evaluated twice-weekly administration of 3 different doses — 28, 56, and 84 mg — all of which produced improvement in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) within one week, with the effect being dose related.
Janssen Global Head, Neuroscience Therapeutic Area, Husseini K. Manji, commented, “About one third of patients with major depressive disorder do not respond to current treatment options. The results of this study reinforce the potential of esketamine as a treatment for patients with treatment-resistant depression and support further clinical research, providing hope for people in need. If approved by the FDA, esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years.”
Read the Janssen press release.