Valdoxan’s antidepressant efficacy has been demonstrated in a large clinical program including 5 800 patients of whom 3 900 were treated with Valdoxan. The short-term efficacy of Valdoxan has been demonstrated over treatment periods of 6 to 12 weeks using standardized scales (Hamilton Depression Rating Scale [HAMD], Montgomery and Asberg Depression Rating Scale [MADRS], Clinical Global Impression-Improvement [CGI-I] and Clinical Global Impression-severity [CGI-S] scales) versus placebo and active comparators.

Valdoxan resulted in significant improvements in HAMD scores at week 6 and week 8. Furthermore, Valdoxan provided high HAMD response rate at week 6 and high MADRS remission rate at week 12.

Significant improvement at week 6 with Valdoxan

The antidepressant efficacy of Valdoxan 25 mg to 50 mg has been demonstrated in a 6-week, randomized, double-blind, placebo-controlled, parallel-group study in 260 patients with MDD.

After 6 weeks of treatment, the difference in HAMD total score between Valdoxan and placebo was 3.44 (P<0.001), with a significant difference from placebo after only 2 weeks of treatment (P<0.05).

Olié JP, Kasper S. Int J Neuropsychopharmacol. 2007;10:661-673.

Significant improvement at week 8 with Valdoxan

In a 8-week, dose-finding, double-blind placebo-controlled study conducted in 711 MDD patients, the antidepressant efficacy of Valdoxan has been illustrated by a significant difference in mean HAMD final scores in favor of Valdoxan 25mg showed (mean difference=2.57 in favor of Valdoxan 25 mg/day versus placebo, P<0.05).

Lôo H, Hale A, D’haenen H. Int Clin Psychopharmacol. 2002;17:239-247.

High response rate at week 6 with Valdoxan

Lemoine P. et al. J Clin Psychiatry. 2007;68:1723-1732.

In a 6-week, randomized double-blind comparative study comparing Valdoxan 25-50 mg/day and venlafaxine IR 75-150 mg/day in 332 MDD patients, 76% of Valdoxan-treated patients were responders after 6 weeks of treatment versus 70.6% in the venlafaxine treatment arm. Note: response was defined as a HAMD baseline score improvement of 50% or more.

High remission rate at week 12 with Valdoxan

Kennedy S, Rizvi S, Fulton K, Rasmussen J. J Clin Psychopharmacol. 2008;28:329-333.

In a 12-week, randomized double-blind comparative study comparing Valdoxan 50 mg/day and venlafaxine XR 150 mg/day in 276 MDD patients, 73% of Valdoxan-treated patients were in remission after 12 weeks of treatment versus 66.9% in the venlafaxine treatment arm. Note: remission was defined as a MADRS total score ≤ to 12 at week 12.

Efficacy in acute phase Efficacy in maintenance phase