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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT05345392
Eligibility Criteria:
Inclusion Criteria:
* Males and females between the ages of 11-14 years
* Parent or full biological sibling with major depressive disorder and/or bipolar I/II disorder
* Elevated mood lability, which is defined as \>10 on the Children's Affective Lability Scale (averaging the child and parent score).
Exclusion Criteria:
* IQ\<70 or significant learning disability (which will make it difficult to participate in study procedures)
* Current or previous diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or autism spectrum disorder
* Current diagnosis of major depressive disorder
* Contraindications to scanning, including metal in the body (e.g. has braces or planning to get braces within the next 8 months)
* Suicidal or homicidal ideation within the past month
* Changed medications or medication doses (including psychotropic medications and/or hormonal contraceptives), or have started a new therapy, within the past two months.
For each eligible youth, a parent (when possible, the parent with a mood disorder) will also be enrolled in the study, to provide a detailed account of family history. The only inclusion criterion for the parent participants is that they have an eligible child.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
14 Years
Study:
NCT05345392
Study Brief:
Protocol Section:
NCT05345392