Valdoxan provides MDD patients with a significant symptomatic relief, as demonstrated by well-documented improvements in depressed mood, anxiety symptoms, and also sleep-wake disturbances (daytime impairment and sleep disturbances).

Efficacy of Valdoxan on depressed mood

Valdoxan has been demonstrated to be significantly effective in relieving depressed mood of patients with MDD, the most characteristic symptom of depression.

In a 6-week randomized double-blind placebo-controlled study, a significant difference between Valdoxan and placebo groups in favour of Valdoxan was observed for the response to item 1 (depressed mood) on the HAMD [mean difference= 0.32, P=0.015].

Efficacy of Valdoxan on anxiety symptoms

Valdoxan has been demonstrated to be significantly effective in relieving anxiety symptoms of depressed patients, as assessed by the Hamilton Anxiety Rating Scale (HAMA).

In an 8-week, randomized double-blind placebo-controlled study, Valdoxan demonstrated a significant difference in the mean final HAMA score (P<0.05) compared with placebo.

Efficacy of Valdoxan on sleep-wake disturbances

Valdoxan has been demonstrated to significantly improve sleep disturbances and daytime functioning of depressed patients as measured on the Leeds Sleep Evaluation Questionnaire (LSEQ).
This significant and differentiating advantage of Valdoxan has been documented after 1 and 6 weeks of treatment in a 6-week randomized, double-blind study conducted versus active comparator.

Efficacy in maintenance phase Efficacy in moderate to severe depression