Status:
COMPLETED
Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder
Lead Sponsor:
The National Brain Mapping Laboratory (NBML)
Collaborating Sponsors:
Leibniz Research Centre for Working Environment and Human Factors
Neuroelectrics Corporation
Conditions:
Depressive Disorder
Cognitive Impairment
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation int...
Eligibility Criteria
Inclusion
- Meet DSM-5 criteria for a moderate-to-severe major depression, primarily by a DSM-5-based structured interview by a licensed psychiatrist, confirmed by score on Hamilton Rating Scale for Depression (HAMD)
- being 18-60 years old
- providing written informed consent
- If female, negative urine pregnancy test
- Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclics (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention
Exclusion
- smoker
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
- comorbid Schizophrenia Axis I disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder
- history of head injury
- currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
- Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06165445
Start Date
June 1 2021
End Date
March 1 2023
Last Update
May 8 2025
Active Locations (1)
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1
Zanjan University of Medical Sciences
Zanjan, Zanjan Province, Iran