NCT06758167

RCT Study on the Therapeutic Effect of Escitalopram Loaded With XingpiJieyu Formula on Resting State EEG Energy Abnormalities in Severe Liver Depression and Spleen Deficiency Type MDD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Peking University Sixth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the clinical efficacy of XingpiJieyu formula or its placebo combined with Escitalopram (ESC) in the treatment of moderate and severe MDD, and to explore a new method of integrated traditional Chinese and western medicine for the treatment of moderate and severe MDD with severe liver depression and spleen deficiency, as well as its neurological mechanism for regulating the relative power (RP) of resting-state EEG spectra.

Detailed description

MDD patients, especially severe MDD patients have heavy burden of disease, high risk of suicide, difficulty in single drug treatment, and poor compliance with combined western medicine treatment. It is urgent to explore new methods of integrated traditional Chinese and western medicine in the treatment of moderate and severe MDD to enhance efficacy and reduce toxicity. A double-blind, randomized, controlled Trial (RCT) was conducted to compare the efficacy of XingpiJieyu formula or its placebo combined with escitalopram in the treatment of MDD with severe liver depression and spleen deficiency. We aim to explore the clinical efficacy of XingpiJieyu formula combined with escitalopram and its possible multi-target neural mechanism.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	XingpiJieyu formula	XingpiJieyu formula is a traditional Chinese medicine. It pays attention to the regulation of qi and blood. Previous studies have shown that its clinical effect of treating mild and moderate depression is significant, for example, it can effectively improve depressive mood and somatic symptoms, and increase peripheral blood ATP levels in patients with depression.
DRUG	Placebo	Placebo, no therapeutic effect.
DRUG	Escitalopram	A commonly used drug in MDD treatment.

Timeline

• Start date: 2020-11-14
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

1 site across 1 country: China