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Completed

NCT Number: NCT03632434

Transcranial Direct Current Stimulation Therapy for Major Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of East London

London, E15 4LZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Other names: tDCS

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of East London

Other

Collaborators

  • King's College London
  • Rosetrees Trust
  • University College, London
  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2018
Registry last updated
Aug 1, 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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