Major DepressionNCT06758167

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

A study testing XingpiJieyu formula and Escitalopram in people with Major Depression, run by Peking University Sixth Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Major Depression
What is being tested?: XingpiJieyu formula and Escitalopram
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteChina
Study dates: 14 Nov 2020to 2 Apr 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Read the 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
Being tested: XingpiJieyu formula, Placebo, Escitalopram
Keywords: Depression, XingpiJieyu Formula, Escitalopram, Relative Energy, Electroencephalogram
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XingpiJieyu formulaDrug
Also called XPJYF
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.
PlaceboDrug
Also called PLA
Placebo, no therapeutic effect.
EscitalopramDrug
Also called ESC
A commonly used drug in MDD treatment.

Study groups in NCT06758167
Study group	Role	What they receive
XingpiJieyu formula	Experimental	Experimental group, treated with XingpiJieyu formula and escitalopram. Receives: Drug: XingpiJieyu formula; Drug: Escitalopram
Placebo and escitalopram	Placebo comparator	Control group, treated with placebo and escitalopram. Receives: Drug: Placebo; Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

17-item Hamilton Depression Scale (HAMD-17)
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.
Measured: 8 weeks
Hamilton Anxiety Scale (HAMA)
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.
Measured: 8 weeks
Health Questionnaire-15 (PHQ-15)
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.
Measured: 8 weeks
Pittsburgh sleep quality index (PSQI)
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.
Measured: 8 weeks
Treatment Emergent Symptom Scale (TESS)
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 20202 Apr 2024

First posted3 Jan 2025
Study start14 Nov 2020
Primary completion2 Apr 2024
Study completion2 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06758167
Sponsor's protocol ID: 2019-37-1
Status last verified: Dec 2024
First submitted: 25 Dec 2024
Last updated: 3 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06758167
Acronym / sponsor ID: 2019-37-1
Conditions: Major Depression
Keywords: Depression, XingpiJieyu Formula, Escitalopram, Relative Energy, Electroencephalogram
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Peking University Sixth HospitalUniversity, hospital or other
Study start: 14 Nov 2020 (actual)
Primary completion: 2 Apr 2024 (actual)
Study completion: 2 Apr 2024 (actual)
First posted: 3 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
XingpiJieyu formula	Experimental	Drug: XingpiJieyu formula, Drug: EscitalopramExperimental group, treated with XingpiJieyu formula and escitalopram.
Placebo and escitalopram	Placebo comparator	Drug: Placebo, Drug: EscitalopramControl group, treated with placebo and escitalopram.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XingpiJieyu formulaAlso: XPJYFXingpiJieyu 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	XingpiJieyu formula
PlaceboAlso: PLAPlacebo, no therapeutic effect.	Drug	Placebo and escitalopram
EscitalopramAlso: ESCA commonly used drug in MDD treatment.	Drug	Placebo and escitalopram, XingpiJieyu formula

Primary outcome

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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Major Depression

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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
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Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xueqin Wang, Doctor principal investigator

Peking University Sixth Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing XingpiJieyu formula and Escitalopram in people with Major Depression, run by Peking University Sixth Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

17-item Hamilton Depression Scale (HAMD-17) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.