1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
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1. What is the clinical proof of VALDOXAN’s antidepressant efficacy?
The antidepressant efficacy of VALDOXAN has been confirmed in four trials versus placebo, three over the short term and one over the long term. The antidepressant efficacy of VALDOXAN is significantly superior to that of placebo, as mentioned in the Valdoxan SPC, whatever the symptom intensity, [...]

A Long-term efficacy of Valdoxan: prevention of relapses at 6 months
The maintenance of antidepressant efficacy of Valdoxan was demonstrated over a treatment period of 6 months in a relapse prevention study. Patients responding to 8/10-weeks of acute treatment with open-label Valdoxan 25 to 50 mg once daily were randomized to either Valdoxan 25 or 50 [...]

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 [...]

Valdoxan’s onset of efficacy has been reported and measured on the Clinical Global Impression-Improvement [CGI-I] scale and Visual Analog Scales [VAS]as early as the first week of treatment. From the first week of treatment, Valdoxan demonstrated to provide significant efficacy in terms of CGI score improvement, as well as VAS score improvement.
Significant improvement in CGI [...]