Safety and Efficacy of Jiaotai Wan in Patients with Depression: Study Protocol for a Randomized Controlled Trial

Abstract Backgroud: Depression is a common affective disorder characterised by marked and lasting melancholia, with corresponding thought and behaviour changes. Due to an accelerated pace of life and increased work pressure, the incidence of depression has risen sharply, causing great harm to family and social life. Jiaotai Wan (JTW) is a Chinese herbal formula that is commonly prescribed for depression and insomnia in clinical treatment, and exhibits antidepressant effects as shown in animal experimental research. However, there are no standard clinical trials to confirm its efficacy in treating depression and insomnia. Therefore, this study aims to assess the efficacy and safety of JTW in the treatment of depression. Methods: A randomized, multicentre clinical trial with parallel groups was designed in this study. A total of 40 patients with depression were included and randomly divided to either the treatment or the control group with a ratio of 1:1. The patients received JTW plus fluoxetine or fluoxetine alone once per day for eight weeks. The primary outcome was analysed using the Hamilton Depression Rating Scalescore for patients in the treatment group compared with that in the control group. The secondary outcomes included Traditional Chinese medicine syndrome integral scale scores, Wisconsin Card Sorting Test, blood metabonomics, urine metabonomics, and brain structure and function by functional magnetic resonance imaging. Discussion: The results of this trial will find changes in brain structure, brain function, and metabolism in patients with depression, and provide critical evidence for JTW in the treatment of depression.