Transcranial Direct Current Stimulation Therapy for Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT03632434
• Lead Sponsor: University of East London

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.

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Study Start: 2019-10-14
• Primary Completion: 2021-11-26
• Study Completion: 2021-11-26
• Results First Submitted: 2023-05-19
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active tDCS	transcranial direct current stimulation	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.

Primary Outcome Measures

Name	Time	Method
Clinical Response	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.

Trial Locations

Locations (1)

University of East London; 🇬🇧 London, United Kingdom