Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Inclusion Criteria:

• Clinical Diagnosis of MDD
• Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode

Exclusion Criteria:

• Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months