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 @ 12:13 PM
Ignite Modification Date:
2025-12-24 @ 12:13 PM
NCT ID:
NCT05840861
Eligibility Criteria:
Inclusion Criteria:
* Meet DSM-V criteria for a current depressive episode.
* Being first-episode patients who were medication-naïve;
* Score \>17 on 17-item Hamilton Depression Rating Scale (HDRS), score \>22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score \<6 on Young Mania Rating Scale (YMRS).
* Age 18 to 35.
* Able to give written informed consent.
Exclusion Criteria:
* Have a current or past significant medical, neurological or metabolic disorder or head injury
* Have active, significant suicidal ideation or past suicide attempts
* Have implanted metallic devices or any MR contraindications
* Are women who are pregnant or breastfeeding
* Met DSM-5 criteria for substance use disorder
* Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)
* Are MDD patients present with delusions and/or hallucinations
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05840861
Study Brief:
Protocol Section:
NCT05840861