# Efficacy and safety of Shugan Jieyu Capsule in the treatment of depressive state after acute coronary syndrome: study protocol for a multicenter randomized controlled trial

## TL;DR

This study will test if Shugan Jieyu Capsules are effective and safe for treating depression in patients recovering from heart attacks.

## Contribution

This is the first multicenter, placebo-controlled trial to evaluate Shugan Jieyu Capsules for post-heart attack depression.

## Key findings

- The study will assess the impact of Shugan Jieyu Capsules on depression severity using the HAMD-17 scale.
- Metabolomic analysis will explore the biological mechanisms of Shugan Jieyu Capsules in treating post-ACS depression.
- Safety and long-term cardiovascular outcomes will be evaluated alongside depression improvement.

## Abstract

This study aims to evaluate the efficacy and safety of Shugan Jieyu Capsules (SGJY) in patients with depressive state after Acute Coronary Syndrome (ACS).

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 148 patients with depressive state after ACS recruited from five research centers, will be randomly assigned to either the SGJY group or the placebo group at a 1:1 ratio. In addition to standard therapies for ACS, the SGJY group will receive SGJY while the placebo group will receive a matching placebo. All participants will undergo 12 weeks of treatment, followed by 36 weeks of follow-up.

The primary outcome is the Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes include major adverse cardiovascular and cerebrovascular events (MACCE), Seattle Angina Questionnaire (SAQ) score, depression and anxiety scales, the Short Form-36 (SF-36) health survey, Montreal Cognitive Assessment (MoCA) score, inflammatory cytokine levels, hypothalamic-pituitary-adrenal (HPA) axis activity, and brain-derived neurotrophic factor (BDNF) levels. Safety will be evaluated based on safety indicators and recorded adverse events. Additionally, metabolomic analysis will be conducted on patient serum samples collected before and after treatment to elucidate the potential metabolic pathways of SGJY ameliorates subthreshold depression after ACS.

This trial will evaluate the efficacy and safety of SGJY in managing depressive state after ACS. Additionally, the potential of SGJY to improve long-term prognosis in patients with depressive state after ACS will be assessed.