Work

Efficacy and safety of Toludesvenlafaxine extended-release tablets in the treatment of treatment-resistant depression

Year: 2025

Type: article

Abstract: BACKGROUND: Treatment-resistant depression (TRD) is a major challenge in clinical psychiatry, characterized by insufficient response to at least two different classes of antidepressants. Despite advances in treatment, many TRD patients continue to experience significant symptoms and reduced quality of life. The study aims to provide an exploratory assessment of toludesvenlafaxine hydrochloride sustained-release tablets for efficacy and safety in TRD. METHODS: We conducted an open-label, single-arm, exploratory 8-week study in adults with TRD (n = 31) receiving Toludesvenlafaxine. The primary endpoint was the change in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week 8. Secondary endpoints included changes in anxiety, quality of life, and functional status, as well as the assessment of safety. RESULTS: Within-group improvements were observed in MADRS scores at weeks 2, 4, and 8 compared with baseline (P < 0.0001), with an average reduction of -13.0 ± 9.6 at week 8. The MADRS response rate (≥ 50% reduction) was 22.6% at week 4 and 45.2% at week 8, while the remission rate (MADRS ≤ 12) was 9.7% at week 4 and 29.0% at week 8. Secondary outcomes, including the Hamilton Anxiety Rating Scale (HAMA), the Sheehan Disability Scale (SDS), and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF), showed significant improvements from baseline. Toludesvenlafaxine was well-tolerated, with a low incidence of adverse events, none of which were severe. CONCLUSION: These findings suggest that Toludesvenlafaxine may be associated with improvements in both depressive and anxiety symptoms, as well as quality of life, in patients with TRD. This study provides evidence supporting the use of Toludesvenlafaxine as an effective treatment option for TRD and emphasizes the need for further research to confirm its long-term efficacy and safety. TRIAL REGISTRATION: The study strictly adhered to the TREND guidelines, Chinese clinical trial Registry, ChiCTR2400080665, 2024-02-04. CLINICAL TRIAL NUMBER: RXL-SAT-06.

Source: BMC Psychiatry

DOI: 10.1186/s12888-025-07584-8