Transcranial Direct Current Stimulation Therapy for Major Depression

NCT ID: NCT03632434

Last Updated: 2024-08-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2021-11-26

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active tDCS

6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes.

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type 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.

Interventions

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transcranial direct current stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rosetrees Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of East London

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Fu

College Professor of Affective Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Fu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of East London

Locations

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University of East London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Mutz J, Edgcumbe DR, Brunoni AR, Fu CHY. Efficacy and acceptability of non-invasive brain stimulation for the treatment of adult unipolar and bipolar depression: A systematic review and meta-analysis of randomised sham-controlled trials. Neurosci Biobehav Rev. 2018 Sep;92:291-303. doi: 10.1016/j.neubiorev.2018.05.015. Epub 2018 May 12.

Reference Type BACKGROUND
PMID: 29763711 (View on PubMed)

Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ. 2019 Mar 27;364:l1079. doi: 10.1136/bmj.l1079.

Reference Type BACKGROUND
PMID: 30917990 (View on PubMed)

Woodham R, Rimmer RM, Mutz J, Fu CHY. Is tDCS a potential first line treatment for major depression? Int Rev Psychiatry. 2021 May;33(3):250-265. doi: 10.1080/09540261.2021.1879030. Epub 2021 Mar 11.

Reference Type BACKGROUND
PMID: 33706656 (View on PubMed)

Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8.

Reference Type RESULT
PMID: 35839661 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A1950

Identifier Type: -

Identifier Source: org_study_id

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