US-based biopharmaceutical firm Cerecor has started dosing in Clin301-203, a Phase II trial of an antidepressant product candidate CERC-301 to treat major depressive disorder (MDD).

CERC-301 is an NR2B specific, N-methyl-D-aspartate (NMDA) antagonist, which is believed to have the potential to provide a rapid onset of antidepressant effect.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The company is mainly focused on developing new drugs for patients with neurological and psychiatric disorders.

The randomised, double-blinded, placebo-controlled Phase II trial will evaluate the antidepressant effect of 12mg and 20mg doses of CERC-301.

"The Phase II Clin301-203 trial includes two intermittent dose administrations seven days apart.quot;

Approximately 104 subjects with MDD, who are currently experiencing a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI), will be enrolled in the trial.

See Also:

Cerecor co-founder and CEO Blake Paterson said: "Ketamine has recently attracted interest for its rapid antidepressant effect in multiple clinical studies, however, its adverse side effect profile and requirement for physician administration have stymied its development for treatment-resistant MDD.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"Although CERC-301’s mechanism of action is based on ketamine, it is orally administered, has the potential to minimize side effects through its selectivity for NR2B, and provides a therapeutic option for patients with depression who are not responding to standard treatments."

The Phase II Clin301-203 trial includes two intermittent dose administrations seven days apart, followed by 14 days of observation.

The trial’s primary objective is to evaluate the antidepressant effect of CERC-301, in 12mg and 20mg dosages, compared to placebo as evaluated by the six-item unidimensional sub-set of the Hamilton Depression Rating Scale.