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Clinical Trials/NCT03632434
NCT03632434
Completed
Not Applicable

Acceptability and Feasibility of Transcranial Direct Current Stimulation Therapy as a Community-based Treatment for Major Depression

University of East London1 site in 1 country26 target enrollmentOctober 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of East London
Enrollment
26
Locations
1
Primary Endpoint
Clinical Response
Status
Completed
Last Updated
last year

Overview

Brief Summary

Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether tDCS can be provided as a home-based treatment for major depression for adults with major depression.

Detailed Description

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS). Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment. The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community. The study research question is whether tDCS could be provided as a home-based treatment for major depression. The study will include adults with major depression.

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
November 26, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cynthia Fu

College Professor of Affective Neuroscience

University of East London

Eligibility Criteria

Inclusion Criteria

  • diagnosis of major depressive disorder based on DSM-5 criteria
  • minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria

  • history of treatment-resistant depression
  • comorbid psychiatric disorder
  • significant risk of suicide or self harm
  • any contraindications to tDCS, including implanted electronic medical devices

Outcomes

Primary Outcomes

Clinical Response

Time Frame: At 6 weeks following course of tDCS treatment

As measured by a Hamilton Depression Rating Scale score that is less than or equal to 50% of the baseline Hamilton Depression Rating Scale score. Higher scores indicate greater depressive symptoms.

Study Sites (1)

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