- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632434
Transcranial Direct Current Stimulation Therapy for Major Depression
Acceptability and Feasibility of Transcranial Direct Current Stimulation Therapy as a Community-based Treatment 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, E15 4LZ
- University of East London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical response
Time Frame: At 6 weeks following course of tDCS treatment
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As measured by a HAM-D reduction of >= 50%
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At 6 weeks following course of tDCS treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia Fu, MD PhD, University of East London
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1950
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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