Magazine article Clinical Psychiatry News

Lu AA21004 Looks Promising for Depression

Magazine article Clinical Psychiatry News

Lu AA21004 Looks Promising for Depression

Article excerpt

ISTANBUL, TURKEY -- The novel investigational agent Lu AA21004 proved effective and very well tolerated for the treatment of depressive and anxiety symptoms in patients with major depression in a double-blind comparison to placebo and venlafaxine.

The study involved 429 outpatients with major depressive disorder at 49 centers in 11 countries who were randomized to Lu AA21004 once daily at 5 or 10 mg/day, venlafaxine XR (Effexor) starting at 75 mg/day and increased to 225 mg/day over the course of the first week, or placebo for 6 weeks, Francesc Artigas, Ph.D., reported at the annual congress of the European College of Neuropsychopharmacology.

Baseline scores on the Montgomery-Asberg Depression Rating Scale (MADRS) averaged 34 points. A clinically significant response, defined as at least a 50% reduction in MADRS scores after 6 weeks, was documented in 67% of patients assigned to the 5-mg dose of Lu AA21004, 68% on Lu AA21004 at 10 mg, 72% of the venlafaxine group, and 45% of placebo-treated controls.

Remission--a MADRS score of 10 or less at 6 weeks--occurred in 49% of patients on either dose of Lu AA21004, 55% with venlafaxine, and 27% with placebo. Significant differences were seen between placebo and both Lu AA21004 and venlafaxine beginning in weeks 2-3.

With an alternative definition of remission, a drop in Hamilton Rating Scale for Depression-24 scores from a mean baseline of 30 to 7 or less at 6 weeks, 47% of patients on the 5-mg dose of Lu AA21004 qualified. So did 45% on Lu AA21004 at 10 mg, 46% on venlafaxine, and 28% on placebo, according to Dr. Artigas of the University of Barcelona.

Mean scores on the Hamilton Rating Scale for Anxiety fell from a baseline of 22 to 10 at 6 weeks in all three active treatment arms. …

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