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Completed

NCT Number: 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

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • outpatient/inpatient, age 18-45 years old, right-handed;
  • western medical diagnosis meets the diagnostic criteria of MDD in DSM-5, without psychiatric features;
  • 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;
  • 17-item Hamilton Depression Scale score ≥18;
  • educational experience ≥5 years;
  • 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;
  • Have not received physical therapy, such as MECT, rTMS, etc., in the past 6 months;
  • The total duration of the disease ≤10 years.

Exclusion criteria

  • Any current or previous mental disorder other than MDD according to DSM-5;
  • 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;
  • Suicidal ideation or suicidal behaviour (HAMD-17 item 3 > 2);
  • Drinking alcohol in the week prior to the enrollment;
  • Patients with neurological disorders, somatic disorders, organic brain diseases, and tumour;
  • 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.

Treatment and study plan

XingpiJieyu formula

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.

Other names: XPJYF

Placebo

Drug

Placebo, no therapeutic effect.

Other names: PLA

Escitalopram

Drug

A commonly used drug in MDD treatment.

Other names: ESC

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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