NCT06758167Completed
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
Source: ClinicalTrials.gov · Last updated 3 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 25 Dec 2024
- Start date
- Nov 2020
- Primary completion date
- Apr 2024
- Lead sponsor
- Peking University Sixth Hospital
- Diseases
- Depression
- NCT number
- NCT06758167
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From Nov 2020 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any current or previous mental disorder other than MDD according to DSM-5;
- Drinking alcohol in the week prior to the enrollment;
Other illness
- 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;
- 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.
Other
- Suicidal ideation or suicidal behaviour (HAMD-17 item 3 \> 2);
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Sixth Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.