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NCT Number: NCT06187454

Transcranial Direct Current Stimulation for Depression

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.

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

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.

Sham Transcranial Direct Current Stimulation

Device

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 outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Mu-N Liu, PhD

CONTACT

[email protected]

0938595767

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2024
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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