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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03742960
Eligibility Criteria:
Inclusion Criteria:
\- This study will recruit adolescents (ages 14 to 17 years) with major depressive disorder (MDD) with insomnia (MDD-INS) and with hypersomnia (MDD-HYP) and age and gender matched controls (HC).
Inclusion Criteria:
Key inclusion criteria for MDD Hypersomnia Group:
* MDD as determined through the MINI-KID
* Determination of hypersomnia as defined by excessive daytime sleepiness, or long sleep duration.
* Written informed consent
Key inclusion criteria for MDD Insomnia Group:
* MDD as determined through the MINI-KID
* Determination of insomnia as defined by the insomnia severity index
* Written informed consent
Exclusion Criteria:
* Key exclusion criteria for all three groups include:
* Current or lifetime experience of frank psychosis or mania
* Presence of suicidal intent representing imminent risk as indicated during clinical interview
* Medical or neurological condition that could impact brain functioning
* History of physical brain injury or blow to the head resulting in loss of consciousness greater than 5 minutes
* Do not meet criteria for substance or alcohol dependence in the last three months
* Presence of an organic sleep disorder (e.g., narcolepsy, sleep apnea)
Additional exclusion criteria for healthy control group:
* Presence of psychiatric disorder
* Self-reported disrupted, short or ill-timed sleep
Additional exclusion criteria for MDD-INS and MDD-HYP:
• No sleep difficulties
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT03742960
Study Brief:
Protocol Section:
NCT03742960