Menu
Recruiting NCT06187454

Transcranial Direct Current Stimulation for Depression

No phase Interventional Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Transcranial direct current stimulation, Sham Transcranial direct current stimulation.
Who it may be relevant to
Registry conditions: Depressive Disorder. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Active Transcranial direct current stimulation
    Transcranial direct current stimulation (tDCS) is a method for noninvasive brain stimulation, where a weak electrical current is delivered through two scalp electrodes by a portable battery-powered stimulator.
  • Device Sham Transcranial direct current stimulation
    For sham tDCS, the electrode positions and stimulation parameters will be the same as that used for anodal stimulation except that the current will be delivered only for the initial 30 seconds.

Primary outcome measures

  • Efficacy and safety of tDCS [Time frame: 8 Weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • TaipeiVGH — Taipei

Identifiers

NCT: NCT06187454 · 2020-07-020B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗