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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06758167
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06758167
Study Brief:
Protocol Section:
NCT06758167