Effectiveness and Safety of Venlafaxine in Japanese Major Depressive Disorder Patients with or without Anxious Distress (EXPAND Study): A 12-Week Prospective Observational Study.

PURPOSE: This study evaluated outcomes of venlafaxine treatment in Japanese patients with major depressive disorder (MDD) in routine clinical practice. Since anxiety is a common and clinically relevant feature of MDD, descriptive analyses were conducted based on the presence or absence of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) anxious distress. PATIENTS AND METHODS: This 12-week, multicenter, single-arm, observational study consecutively enrolled adult patients with MDD initiating venlafaxine in Japan. DSM-5 anxious distress was assessed at baseline. The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 12 or discontinuation. Secondary endpoints included MADRS response and remission rates, patient-reported outcomes, and safety. Analyses were descriptive and conducted by anxious distress status. RESULTS: Among enrolled patients, 407 received venlafaxine and comprised the safety analysis set; 198 (48.6%) had anxious distress. MADRS total score decreased from baseline to week 12 or discontinuation in the overall population and in patients with and without anxious distress. Patients with anxious distress had higher baseline symptom severity but showed improvement over time. Similar improvements were seen across secondary patient-reported outcomes in both subgroups. Drug-related adverse events and discontinuations due to adverse events were numerically more frequent in patients with anxious distress. The safety profile was in line with established findings. CONCLUSION: Venlafaxine treatment in clinical practice improved depressive symptoms, anxiety, functioning, quality of life, and cognitive complaints in patients with MDD. Improvements were seen in patients with and without anxious distress. These results provide descriptive real-world evidence on treatment outcomes; however, they should be interpreted with caution given the non-comparative study design and other limitations. The findings may inform clinical decision-making in patients with heterogeneous presentations encountered in routine psychiatric practice.