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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03632434
Other study ID # A1950
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date November 26, 2021

Study information

Verified date June 2022
Source University of East London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 26, 2021
Est. primary completion date November 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
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.

Locations

Country Name City State
United Kingdom University of East London London

Sponsors (5)

Lead Sponsor Collaborator
University of East London King's College London, Rosetrees Trust, University College, London, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical response As measured by a HAM-D reduction of >= 50% At 6 weeks following course of tDCS treatment
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