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Transcranial Direct Current Stimulation Therapy for Major Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University of East London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of East London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical response
As measured by a HAM-D reduction of >= 50%

Secondary Outcome Measures

Full Information

First Posted
August 8, 2018
Last Updated
June 22, 2022
Sponsor
University of East London
Collaborators
Rosetrees Trust, King's College London, University College, London, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03632434
Brief Title
Transcranial Direct Current Stimulation Therapy for Major Depression
Official Title
Acceptability and Feasibility of Transcranial Direct Current Stimulation Therapy as a Community-based Treatment for Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of East London
Collaborators
Rosetrees Trust, King's College London, University College, London, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response
Description
As measured by a HAM-D reduction of >= 50%
Time Frame
At 6 weeks following course of tDCS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Fu, MD PhD
Organizational Affiliation
University of East London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of East London
City
London
ZIP/Postal Code
E15 4LZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
Individual access by request
Citations:
PubMed Identifier
29763711
Citation
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.
Results Reference
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PubMed Identifier
30917990
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.
Results Reference
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PubMed Identifier
33706656
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.
Results Reference
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Transcranial Direct Current Stimulation Therapy for Major Depression

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