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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT06698666
Eligibility Criteria:
Inclusion Criteria:
* aged between 20 and 45 years;
* diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);
* The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;
* the ability to give informed consent and to comply with standard procedures;
* Males and females; and
* Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated.
Exclusion Criteria:
* lifetime or current SCID-I/P diagnosis of a psychotic disorder;
* lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;
* acute or unstable systemic medical disorder;
* inability to comply with the requirements of informed consent or the study protocol;
* history of intolerance or allergy to study medications;
* Current pregnancy or breast feeding;
* Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and
* Females on Contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT06698666
Study Brief:
Protocol Section:
NCT06698666