Transcranial Direct Current Stimulation Therapy for Bipolar Depression

NCT05436613 | Completed Results

• 1 other identifier: 308690
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

Conditions

Depression, Bipolar; Bipolar Disorder; Mood Disorders; Mental Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]

  As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment.

  6 weeks

Secondary Outcomes (2)

• Participant Retention at the End of the Treatment

  6 weeks (visit 21)

• Participant Acceptability Questionnaire Scales

  Week 6 (Visit 21)

Other Outcomes (1)

• MADRS Remission Rate

  6 weeks (Visit 21)

Study Arms (1)

Device: transcranial direct current stimulation

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 at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks.

Device: transcranial direct current stimulation

Eligibility Criteria

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

You may qualify if:

• diagnosis of bipolar disorder based on DSM-5 criteria
• minimum score of 18 on the MADRS
• being on a stable dosage of mood stabilizing medication for a minimum of two weeks

You may not qualify if:

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

Sponsors & Collaborators

• University of East London: lead
• University College, London: collaborator
• King's College London: collaborator
• Technische Universität Dresden: collaborator

Study Sites (1)

University of East London

London, E16 2RD, United Kingdom

Location

Related Publications (7)

• 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 BACKGROUND

• Rezaei H, Woodham RD, Ghazi-Noori AR, Ritter P, Bauer M, Young AH, Bramon E, Fu CHY. Acceptability of home-based transcranial direct current stimulation (tDCS) in bipolar depression: thematic analysis of individual views. BMC Psychiatry. 2025 May 26;25(1):549. doi: 10.1186/s12888-025-06948-4.

  PMID: 40420071 DERIVED

• Rezaei H, Woodham RD, Ghazi-Noori AR, Ritter P, Bauer M, Young AH, Bramon E, Fu CHY. Acceptability of Home-Based Transcranial Direct Current Stimulation (tDCS) in Bipolar Depression: Thematic Analysis of Individual Views. Res Sq [Preprint]. 2025 Apr 15:rs.3.rs-5967699. doi: 10.21203/rs.3.rs-5967699/v1.

  PMID: 40321750 DERIVED

• Ghazi-Noori AR, Woodham RD, Rezaei H, Sharif MS, Bramon E, Ritter P, Bauer M, Young AH, Fu CHY. Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events. Int J Bipolar Disord. 2024 Aug 20;12(1):30. doi: 10.1186/s40345-024-00352-9.

  PMID: 39162912 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Mental Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

c.fu@uel.ac.uk

020 8223 4119

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: June 23, 2022
• First Posted: June 29, 2022
• Study Start: May 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)