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

NCT ID: NCT06758167

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-14
• Study Completion Date: 2024-04-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XingpiJieyu formula

Experimental group, treated with XingpiJieyu formula and escitalopram.

Group Type: EXPERIMENTAL

XingpiJieyu formula

Intervention Type: DRUG

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.

Escitalopram

Intervention Type: DRUG

A commonly used drug in MDD treatment.

Placebo and escitalopram

Control group, treated with placebo and escitalopram.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, no therapeutic effect.

Escitalopram

Intervention Type: DRUG

A commonly used drug in MDD treatment.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo, no therapeutic effect.

Intervention Type: DRUG

Escitalopram

A commonly used drug in MDD treatment.

Intervention Type: DRUG

Other Intervention Names

XPJYF; PLA; ESC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Sixth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xueqin Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xueqin Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Locations

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2019-37-1

Identifier Type: -

Identifier Source: org_study_id