Transcranial Direct Current Stimulation for Depression

NCT06187454 | Recruiting

• 1 other identifier: 2020-07-020B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy and safety of tDCS

  \[Primary Outcome Measures\] * 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.

  8 Weeks

Study Arms (2)

Active tDCS

EXPERIMENTAL

Device: Active Transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Device: Sham Transcranial direct current stimulation

Interventions

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.

Active tDCS

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.

Sham tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

TaipeiVGH

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Central Study Contacts

Mu-N Liu, PhD

CONTACT

0938595767; liumuen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 2, 2024
• Study Start: September 8, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)