US-based biopharmaceutical firm Cerecor has received IND clearance from the US Food and Drug Agency (FDA) to start a Phase II clinical trial of its oral, selective NMDA receptor subunit 2B (NR2B) antagonist CERC-301 for the adjunctive treatment of subjects with major depressive disorder (MDD) who have not adequately responded to their current therapy and report recent suicidal ideation.
A total of 135 patients will participate in the placebo-controlled Phase II study, which was designed with input from a panel of clinical experts in the treatment of depression to evaluate CERC-301 as adjunctive treatment.
In the trial, the safety and efficacy of CERC-301 will be assessed over 28 days of treatment, and the primary endpoint is the change in the Hamilton Depression Rating Scale at day seven.
The trial includes MDD patients who would likely benefit most from rapid onset antidepressant activity, those who are failing existing selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment.
Patients who had recent active suicidal ideation and are deemed appropriate for an out-patient study with careful safety surveillance will also be treated in the study.
University of Alabama Charles B Ireland Professor and vice-chair for research Richard Shelton said patients who experience severe depression, often with thoughts of suicide, have few options for treatment.
"There is a clear need for a rapid-acting antidepressant for these patients who are not fully responding to their current therapy," Shelton said.
"The pilot study performed by the NIMH suggests that CERC-301 has the potential to provide rapid relief, in a fashion similar to clinical effects seen with other NMDA-receptor blockers."
The main aim of the sequential parallel comparison design in the Phase II trial of CERC-301 is to overcome the challenges of placebo response frequently observed in depression trials.
Cerecor expects to release results of the Phase II clinical study of CERC-301 in the second half of 2014.
A pilot study carried out by the National Institute of Mental Health (NIMH) in five patients with treatment-resistant depression (TRD) showed that CERC-301 was well-tolerated and despite the small sample size, results suggested that an oral formulation of the drug candidate may have rapid antidepressant properties in TRD patients.
In addition, CERC-301 demonstrated rapid antidepressant efficacy in patients with treatment-resistant depression in an exploratory proof-of-concept study published in 2012.
The company said that CERC-301 has the potential to be a first-in-class oral medication that is complimentary to current treatments in patients with depression who have not adequately responded to their current therapy.