Cerecor released clinical results from a sponsored trial on CERC-501 in treatment-resistant depression.
Cerecor (NASDAQ:CERC) released clinical results from a sponsored trial on CERC-501 in treatment-resistant depression.
As quoted in the press release:
In this sequential parallel comparison design (“SPCD”) trial entitled, Proof of Concept Trial of CERC-501 Augmentation of Antidepressants Therapy in Treatment Resistant Depression, CERC-501 showed a clinically meaningful 2.0-point difference from placebo on the Hamilton Rating Scale for Depression – 6 – items (“HAM-D-6”), change from baseline to 72 hours, which served as the primary efficacy measure. A 2.0-point difference between CERC-501 and placebo on the HAM-D-6 is comparable to a 4.0-point difference on the Hamilton Depression Rating Scale-17 (HDRS-17). Clinically meaningful differences were also observed across multiple, pre-specified, secondary outcome measures:
- Number of Responders (50% or greater reduction) on the HAM-D-6 at 72 hours
- Change in Montgomery-Asberg Depression Rating Scale (“MADRS”)
- Change in the Perceived Stress Scale (“PSS”)
- Change in Clinical Global Impression Severity (“CGI-S”)
- Clinical Global Impression Improvement (“CGI-I”) Score
- Change in Symptoms of Depression Questionnaire (“SDQ”)
- Change in Positive Affect Scale (“PAS”)
“These results provide additional support for the development of CERC-501 as an adjunctive treatment of major depressive disorder (‘MDD’),” said Uli Hacksell, Ph.D., Chief Executive Officer and Chairman of Cerecor. “We want to thank the NIMH for supporting the trial.”