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Trial record 1 of 1 for:    A1950
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Transcranial Direct Current Stimulation Therapy for Major Depression

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ClinicalTrials.gov Identifier: NCT03632434
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
King's College London
University of Oxford
University College, London
Information provided by (Responsible Party):
Cynthia Fu, 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: transcranial direct current stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability and Feasibility of Transcranial Direct Current Stimulation Therapy as a Community-based Treatment for Major Depression
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Other Name: tDCS




Primary Outcome Measures :
  1. Clinical response [ Time Frame: At 6 weeks following course of tDCS treatment ]
    As measured by a HAM-D reduction of >= 50%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632434


Contacts
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Contact: Cynthia Fu 44 (0)208 223 3000 c.fu@uel.ac.uk

Locations
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United Kingdom
University of East London Recruiting
London, United Kingdom, E15 4LZ
Contact: Cynthia Fu, MD PhD       tdep@uel.ac.uk   
Sponsors and Collaborators
University of East London
King's College London
University of Oxford
University College, London
Investigators
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Principal Investigator: Cynthia Fu, MD PhD University of East London

Publications:
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Responsible Party: Cynthia Fu, College Professor of Affective Neuroscience, University of East London
ClinicalTrials.gov Identifier: NCT03632434    
Other Study ID Numbers: A1950
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Starting 6 months after publication
Access Criteria: Individual access by request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders