Transcranial Direct Current Stimulation for Depression

Depressive Disorder Clinical Trial

Official title:

Transcranial Direct Current Stimulation for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187454
• Other study ID #: 2020-07-020B
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Mu-N Liu, PhD
• Phone: 0938595767
• Email: liumuen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Participants who meet the criteria of major depression defined by DSM-5 criteria

2. 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

3. Ambulatory participants with or without any aiding device

Exclusion Criteria:

1. An urgent risk of suicide or severe depression

2. A history of ineffectiveness with tDCS

3. 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

4. Any instable medical condition

5. A history of epilepsy,

6. A history of substance use (within one year)

7. People with dementia or psychotic disorder.

8. Any condition which would make the subject unsuitable for the study under the physician's assessment.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	TaipeiVGH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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