Long-term tolerability and effectiveness of duloxetine in the treatment of major depressive disorder

Forty-one patients (23.1%) experienced adverse events leading to discontinuation during the study.

• Seventy-two of the 177 patients (40.7%) completed the long-term extension phase.
• The mean duration of participation in the extension phase was 305 days, with exposure ranging from 68 to 707 days.
• Only 12 or 13 patients (7.0%) showed clinically significant worsening of depression that led to study discontinuation.
• The mean score on the 17-item Hamilton Depression Rating scale remained below 7 throughout the extension phase.
• Adverse events causing discontinuation were generally not unique to the extension phase, with over half of discontinuations related to earlier reported events.
• Weight gain was reported as a reason for discontinuation in 4 patients (2.3%).

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