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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT04497493
Eligibility Criteria:
Inclusion Criteria:
* a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* age between 18 and 50 years
* a total score of HAMD-17 ≥ 17
* take antidepressants less than 3 days
* Patients are compliant with treatment according to the judgement of the treating clinician.
Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised.
Exclusion Criteria:
* A history of manic episode
* Use of mood stabilizer
* History of substance abuse or dependence
* Severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma.
* Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
* Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04497493
Study Brief:
Protocol Section:
NCT04497493