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Clinical Trials/NCT06187454
NCT06187454
Recruiting
Not Applicable

Transcranial Direct Current Stimulation for Depression

Taipei Veterans General Hospital, Taiwan1 site in 1 country30 target enrollmentSeptember 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
30
Locations
1
Primary Endpoint
Efficacy and safety of tDCS
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Several studies have shown that tDCS is valuable and safe options to improve depressive symptoms in adult patients . However, regarding the tDCS to treat depression in elderly population, only few studies have been reported, and there is no consensus among them. To our knowledge, prefrontal cortex tDCS could be reasonably safe and efficient options for the treatment of several psychiatric illnesses in a population presenting resistance to and/or intolerance of pharmacotherapy . Moreover, the safety tolerability profile of tDCS is a strong argument in favour of exploring their use in the depressed population. Therefore, current study will investigate the efficacy and safety of prefrontal tDCS used as additive treatment in patients with LLD.

Registry
clinicaltrials.gov
Start Date
September 8, 2020
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mu-N Liu

Principal Investigator

Taipei Veterans General Hospital, Taiwan

Eligibility Criteria

Inclusion Criteria

  • Participants who meet the criteria of major depression defined by DSM-5 criteria
  • Participants will be non-responders and taking an antidepressant of adequate dose and for ≥4 weeks in the current episode which has not led to sufficient clinical improvement (defined as a minimum level of 2 on the ATHF); or can't tolerate the adverse effects of antidepressant in the current episode
  • Ambulatory participants with or without any aiding device

Exclusion Criteria

  • An urgent risk of suicide or severe depression
  • A history of ineffectiveness with tDCS
  • People who are clinically contraindicated to receive tDCS intervention or MRI assessment, such as having any brain lesion, intracranial implants (clips, cochlear implants), a tattoo or metal embedded in their scalp or brain
  • Any instable medical condition
  • A history of epilepsy,
  • A history of substance use (within one year)
  • People with dementia or psychotic disorder.
  • Any condition which would make the subject unsuitable for the study under the physician's assessment.

Outcomes

Primary Outcomes

Efficacy and safety of tDCS

Time Frame: 8 Weeks

\[Primary Outcome Measures\] * Hamilton Depression Rating Scale (HAMD) for depression * Comparison of these changes in both sham and active tDCS groups. * Response was defined as ≥ 50% HAMD score improvement from baseline.

Study Sites (1)

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