Transcranial Direct Current Stimulation Therapy for Major Depression

NCT03632434 | Completed Results DMC

• 1 other identifier: A1950
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  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.

  At 6 weeks following course of tDCS treatment

Study Arms (1)

Active tDCS

EXPERIMENTAL

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

Interventions

transcranial direct current stimulation DEVICE

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.

Also known as: tDCS

Active tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of major depressive disorder based on DSM-5 criteria
• minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D)

You may not qualify if:

• history of treatment-resistant depression
• comorbid psychiatric disorder
• significant risk of suicide or self harm
• any contraindications to tDCS, including implanted electronic medical devices

Sponsors & Collaborators

• University of East London: lead
• Rosetrees Trust: collaborator
• King's College London: collaborator
• University College, London: collaborator
• University of Oxford: collaborator

Study Sites (1)

University of East London

London, E15 4LZ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 29763711 BACKGROUND

• 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.

  PMID: 30917990 BACKGROUND

• 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.

  PMID: 33706656 BACKGROUND

• Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8.

  PMID: 35839661 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Due to the open-label design, there was no sham treatment arm and all participants received the active tDCS treatment. Real-time supervision at each session may have contributed to symptom improvement. As the protocol was not designed to establish efficacy, the findings should be considered as preliminary, and a placebo sham treatment control group is required to investigate efficacy.

Results Point of Contact

• Title: Professor Cynthia Fu
• Organization: University of East London

c.fu@uel.ac.uk

07563 240193

Study Officials

• Cynthia Fu, MD PhD

  University of East London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: College Professor of Affective Neuroscience

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 15, 2018
• Study Start: October 14, 2019
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: Individual access by request

Locations

GB (1)