Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06692361
Eligibility Criteria:
Inclusion Criteria (All 8 criterion are met):
* Outpatient or inpatient, aged 18 to 65 years (inclusive), regardless of gender;
* At the start of the screening phase, participants must meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnostic criteria for recurrent major depressive disorder (MDD) or single-episode MDD;
* At the start of the screening phase, participants' score on the 17-item Hamilton Depression Rating Scale (HAMD-17) must be ≥ 17;
* At the start of the screening phase, participants have not been treated with medication for their current depressive episode;
* At the start of the screening phase, participants are intended to be treated with a single antidepressant medication, Escitalopram;
* The HAMD-17 score after two weeks of treatment with the maximum tolerated dose of escitalopram was reduced by less than 20% compared with the HAMD-17 score at screening;
* Participants must have an education level above primary school and be able to understand the content of the scale;
* Participants sign the informed consent form.
Exclusion Criteria (Exclude if 1 criterion is met):
* According to DSM-5 criteria, currently or previously diagnosed as bipolar disorder, neurodevelopmental disorder, neurocognitive disorder, schizophrenia spectrum and other psychotic disorders, substance-related and addiction disorders;
* Accompanied by significant psychotic symptoms (delusions, hallucinations, etc.);
* The patient currently has severe or unstable central nervous system, cardiovascular, respiratory, liver, kidney, endocrine, blood system or other system diseases, and the researcher believes that the patient is not suitable for inclusion in this study;
* The patient currently has a serious suicide risk, and the HAMD-17 suicide risk item is ≥3 points;
* Suffering from inflammation-related diseases;
* Suffering from gastrointestinal infections, tumors and other structural abnormalities of the digestive system, including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, etc.;
* Previous history of gastrointestinal surgery;
* Continuous use of antibiotics, probiotics, prebiotics or traditional Chinese medicine products for medical purposes for more than 2 weeks within 3 months before enrollment in the study;
* Those who are allergic to capsule ingredients and contents;
* Pregnant or lactating patients;
* Patients who are unable (such as difficulty swallowing) or unwilling to swallow capsules;
* Patients who received MECT treatment in the past 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06692361
Study Brief:
Protocol Section:
NCT06692361