The efficacy and safety of Dayingpian in the treatment of bipolar disorder: A protocol for a non-randomized, open-label trial

Introduction: Dayingpian is prescribed in traditional Chinese medicine, empirically combined with conventional medicines for affective disorders. Clinical experience and the active ingredients suggest its potential therapeutic effect on bipolar depression (BD). However, large-scale evidence to support the efficacy of the add-on treatment for BD in a real-world setting is still lacking. This trial is a preliminary study to assess whether Dayingpian is an effective addition in the treatment of the depressive phase of BD. Methods and analysis: This study was designed as a non-randomized, open-label trial. A total of 200 BD patients (14–65 years) diagnosed in the acute phase are being enrolled. For inclusion, they are required to have a score on the Montgomery-Asberg Depression Rating Scale ≥ 20. Participants are divided into add-on (Dayingpian) or treatment as usual groups at a 1:1 ratio based on the treatments they received. All participants receive adequate pharmacological interventions for BD according to the guidelines. Clinical visits (baseline, 4, 8, and 12 weeks) mainly include psychiatric rating scales for depressive symptom assessment and laboratory tests for safety analysis. The primary outcome is the change from baseline in the Montgomery-Asberg Depression Rating Scale score to week 12. Propensity scoring will be conducted to control confounders before comparisons of efficacy in the 2 groups. Conclusion: This study represents the first clinical trial to explore the efficacy of Dayingpian as an add-on treatment for bipolar depression in a real-world setting. The study results will provide evidence-based medical data for therapeutic guidelines and subsequent research on Dayingpian for the treatment of BD.