Status:
WITHDRAWN
Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression
Lead Sponsor:
Mayo Clinic
Conditions:
Depressive Disorder
Generalized Epilepsy
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief Summary
The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depress...
Detailed Description
Transcranial direct current stimulation (tDCS) has been investigated extensively in recent years for the treatment of depression. Meta-analysis of individual patient data indicates that tDCS results i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03368469
Start Date
February 23 2018
End Date
January 1 2019
Last Update
January 18 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905