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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT03368469
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of generalized epilepsy (confirmed by neurologist)
* Diagnosis of depressive disorder (confirmed by psychiatrist), with CDRS-R score ≥ 40
* Parent/guardian ability to provide written informed consent in English, with child/adolescent participant able to provide assent (for participants \<18 years of age), or participant ability to provide written informed consent in English (for participants ≥18 years of age)
* Antidepressant medications (SSRI or SNRI) permitted, provided that no dosing change has occurred in two months prior to baseline assessments; antidepressant medication not required for enrollment
* AED medications (with exceptions listed below in exclusion criteria) permitted, provided that no change in AED regimen has occurred in two months prior to baseline assessments (except for weight/growth-related dosing changes); AED not required for enrollment
Exclusion Criteria:
* Presence of pacemaker or metallic implant (with the exception of orthodontic hardware)
* Prior surgical intervention for epilepsy
* More than one generalized tonic-clonic (GTC) seizure during two months prior to enrollment
* AED regimen change during two months prior to baseline assessments (except dosing adjustments made strictly due to growth/weight change)
* Antidepressant medication change during two months prior to baseline assessments
* Lifetime history of manic/hypomanic episode or psychotic disorder
* Autism spectrum disorder (ASD) diagnosis
* Documented history of intellectual disability (documented full-scale IQ greater than two standard deviations below mean)
* Current or recent (two months prior to baseline assessments) active substance use disorder
* Imminent risk of suicide or medically serious self-injurious behavior (as evaluated by board-certified child and adolescent psychiatrist)
* Current pregnancy or positive urine pregnancy test
* Prohibited concomitant medications include: regularly scheduled benzodiazepines (except clobazam); barbiturates; neuroleptic/antipsychotic medications; lithium.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT03368469
Study Brief:
Protocol Section:
NCT03368469