OPC-34712: Phase II data
A double-blind Phase II trial in 429 adult MDD patients who exhibited an inadequate response to 1-3 antidepressants showed that daily 1.5 mg OPC-34712 as an adjunct to antidepressant therapy met the primary endpoint of significantly improving mean MADRS total scores from baseline to week 6 vs. placebo plus antidepressants (p=0.0303). The daily 0.5 mg dose of OPC-34712 missed the endpoint (p>0.05). The most common adverse events were upper respiratory tract infection, akathisia, weight gain and nasopharyngitis. Data were presented at the American Psychiatric Association meeting in Honolulu.
The study consisted of a screening portion that identified patients who had not responded to prior antidepressant therapy within the current depressive episode; an 8-week, single-blind portion that assessed response status to antidepressant therapy; and the 6-week, double-blind portion. Antidepressants included in the trial were Pristiq desvenlafaxine from Pfizer Inc. (NYSE:PFE, New York, N.Y.); Lexapro ( Cipralex) escitalopram from Forest Laboratories Inc. (NYSE:FRX, New York, N.Y.) and H. Lundbeck A/S (CSE:LUN, Copenhagen, Denmark); and the generics fluoxetine, paroxetine, sertraline and venlafaxine. ...