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

December 25, 2024 updated by: Xueqin Wang, Peking University Sixth Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Sixth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. outpatient/inpatient, age 18-45 years old, right-handed;
  2. western medical diagnosis meets the diagnostic criteria of MDD in DSM-5, without psychiatric features;
  3. In accordance with the diagnostic criteria of depression and liver-stagnation and spleen-deficiency in the "Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine" issued by the China Association of Chinese Medicine in 2008;
  4. 17-item Hamilton Depression Scale score ≥18;
  5. educational experience ≥5 years;
  6. The current episode has not used antidepressants, antipsychotics, mood stabilizers, or other medications that can act on the central nervous system for at least 4 weeks;
  7. Have not received physical therapy, such as MECT, rTMS, etc., in the past 6 months;
  8. The total duration of the disease ≤10 years.

Exclusion Criteria:

  1. Any current or previous mental disorder other than MDD according to DSM-5;
  2. Diagnosis of syndromes other than depression and liver-stagnation and spleen-deficiency in the "Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine" issued by the China Association of Chinese Medicine in 2008;
  3. Suicidal ideation or suicidal behaviour (HAMD-17 item 3 > 2);
  4. Drinking alcohol in the week prior to the enrollment;
  5. Patients with neurological disorders, somatic disorders, organic brain diseases, and tumour;
  6. Sleep disorders other than insomnia disorders currently diagnosed according to DSM-5, such as obstructive sleep apnea syndrome, periodic limb movement disorder, restless legs syndrome, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XingpiJieyu formula
Experimental group, treated with XingpiJieyu formula and escitalopram.
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.
Other Names:
  • XPJYF
Drug: Escitalopram
A commonly used drug in MDD treatment.
Other Names:
  • ESC
Placebo Comparator: Placebo and escitalopram
Control group, treated with placebo and escitalopram.
Drug: Escitalopram
A commonly used drug in MDD treatment.
Other Names:
  • ESC
Drug: Placebo
Placebo, no therapeutic effect.
Other Names:
  • PLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
17-item Hamilton Depression Scale (HAMD-17)
Time Frame: 8 weeks
The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1960 and is the most commonly used scale for clinical assessment of depressive states. This scale is used by two trained raters to conduct a combined HAMD examination of the patient, usually in the form of conversation and observation, and at the end of the examination, the two raters rate independently; by using this scale, the severity of the condition and the effectiveness of the treatment can be evaluated.
8 weeks
Hamilton Anxiety Scale (HAMA)
Time Frame: 8 weeks
Hamilton Anxiety Scale (HAMA), compiled by Hamilton in 1959, is one of the commonly used scales in psychiatric clinics, and the total score of HAMA can better reflect the severity of anxiety symptoms, which can be used to evaluate the severity of anxiety symptoms in patients with anxiety and depression disorders and to assess the effects of various medications and psychological interventions.
8 weeks
Health Questionnaire-15 (PHQ-15)
Time Frame: 8 weeks
The Patient Health Questionnaire-15 (PHQ-15) is a scale used to assess an individual's somatic symptoms and dysfunction. It consists of 15 common somatic symptom items, and assesses a person's somatic health status by asking the participant to select the symptoms that correspond to his or her condition. The scale can be used to screen and assess the presence and severity of clusters of somatic symptoms, helping healthcare professionals to quickly understand a patient's somatic health problems.
8 weeks
Pittsburgh sleep quality index (PSQI)
Time Frame: 8 weeks
The Pittsburgh sleep quality index (PSQI) was compiled in 1989 by Dr Buysse, a psychiatrist at the University of Pittsburgh, USA, and others. The scale is suitable for patients with sleep disorders and patients with psychiatric disorders to evaluate the quality of sleep, but also for the general population to assess the quality of sleep.
8 weeks
Treatment Emergent Symptom Scale (TESS)
Time Frame: 8 weeks
The Side Effects Scale (TESS) is a tool used to assess side effects of medications. It rates side effects in different categories to determine the extent to which a drug is causing side effects in a patient and whether adjustments to the treatment regimen are needed. It can help physicians better understand the side effects of medications and make timely adjustments to treatment regimens to improve outcomes and reduce adverse reactions in patients.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Sixth Hospital

Investigators

  • Principal Investigator: Xueqin Wang, Doctor, Peking University Sixth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2020

Primary Completion (Actual)

April 2, 2024

Study Completion (Actual)

April 2, 2024

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-37-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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