An Evaluation of the Efficacy, Safety, and Tolerability of Desvenlafaxine in the Long-term Treatment of Elderly Outpatients With Major Depressive Disorder.

Objective: To evaluate the safety and tolerability (primary) and efficacy (secondary) of desvenlataxine (administered as desvenlafaxine succinate) treatment in elderly patients with major depressive disorder (MDD). Methods: Outpatients ≥65 years of age with MDD received open-label, flexible-dose desvenlafaxine 100 or 200 mg/day for ≤6 months. Safety and tolerability were assessed,, the primary efficacy measure was the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score. Results: Safety analyses included 52 patients (mean age=72.9 years). The most frequently reported adverse events were mild or moderate nausea (40%), dizziness (25%), and headache (21%). Primary and secondary adverse events led to discontinuation of treatment for 18 (35~) patients. The most common adverse events cited as reasons for withdrawal were hypertension (10%) and nausea (10%). There were few clinically important changes in vital signs, laboratory assessments, or electrocardiograms. Treatment with desvenlafaxine reduced mean total HAM-D17 scores through month 2; these improvements were maintained without dose escalation. Conclusion: Desvenlataxine was safe, well tolerated, and effective in elderly patients with MDD. [ABSTRACT FROM AUTHOR]