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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT07161492
Eligibility Criteria:
Inclusion Criteria:
1. Meets DSM-5 criteria for Major Depressive Episode confirmed by two attending psychiatrists using SCID-5
2. Currently in depressive episode (MADRS ≥22)
3. Stable dose of SSRIs/SNRIs for ≥4 weeks prior to randomization
4. Age 18-45 years
5. Han Chinese ethnicity, right-handed
6. Minimum junior high school education; no color blindness; capable of providing informed consent
7. Willing to sign informed consent and complete all assessments
Exclusion Criteria:
1. Other DSM-5 psychiatric disorders (except MDD)
2. Received non-pharmacotherapy in past 6 months:
* ECT
* rTMS
* Systematic psychotherapy (\>10 sessions)
3. Prior CCRT treatment
4. Medications affecting cognition within specified washout periods:
* Antipsychotics (1 month)
* Cholinesterase inhibitors (donepezil:14d; galantamine:2d)
* Memantine (20d)
* Nootropics (e.g., piracetam:2d)
5. Significant medical comorbidities:
* Thyroid disorders, SLE, diabetes
* Hepatic/renal/pulmonary impairment
* Active infections
* Major trauma
6. History of traumatic brain injury with coma
7. Substance/alcohol abuse or dependence
8. Active suicidal ideation/attempt (MADRS item 10 ≥4)
9. Current corticosteroid therapy
10. Pregnancy, lactation, or planned pregnancy
11. Personal/family history of epilepsy
12. Metallic implants (e.g., pacemaker, dental prostheses)
13. Investigator-determined contraindications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07161492
Study Brief:
Protocol Section:
NCT07161492