Depression, BipolarNCT05436613
Transcranial Direct Current Stimulation Therapy for Bipolar Depression
A study testing Transcranial Direct Current Stimulation in people with Depression, Bipolar and Bipolar Disorder, run by University of East London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar, Bipolar Disorder, Mood Disorders
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- comorbid psychiatric disorder
- significant risk of suicide or self harm
- any contraindications to tDCS, including implanted electronic medical devices
- history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-based Transcranial Direct Current Stimulation Treatment for Bipolar Depression
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.
Read the detailed description
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with 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 present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.
- Conditions
- Depression, Bipolar, Bipolar Disorder, Mood Disorders, Mental Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
tDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
Participant Retention at the End of the Treatment
The number of participants who have completed a minimum of 15 tDCS sessions
Measured: 6 weeks (visit 21)
Participant Acceptability Questionnaire Scales
Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported.
Measured: Week 6 (Visit 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 May 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depression, BipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, King's College London, Technische Universität Dresden
- Responsible party
- Principal investigator, Cynthia Fu, University of East London
- Investigators
- Cynthia Fu, MD, PhD, Principal investigator, University of East London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436613
- Sponsor's protocol ID
- 308690
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2022
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29763711Mutz 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.
PubMed 30917990Woodham 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.
PubMed 33706656Woodham 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.
PubMed 35839661Rezaei 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.
PubMed 40420071Rezaei 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.
PubMed 40321750Ghazi-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.
PubMed 39162912
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Transcranial Direct Current Stimulation Treatment for Bipolar Depression
- ClinicalTrials.gov ID
- NCT05436613
- Acronym / sponsor ID
- 308690
- Conditions
- Depression, Bipolar, Bipolar Disorder, Mood Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of East LondonUniversity, hospital or other
- Collaborators
- University College, London, King's College London, Technische Universität Dresden
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with 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 present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: transcranial direct current stimulation | Experimental | Device: Transcranial Direct Current Stimulation6-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- comorbid psychiatric disorder
- significant risk of suicide or self harm
- any contraindications to tDCS, including implanted electronic medical devices
- history of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationtDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. | Device | Device: transcranial direct current stimulation |
Primary outcome
Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]
Time frame: 6 weeks
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.
2 secondary outcomes
Participant Retention at the End of the Treatment
Time frame: 6 weeks (visit 21)
Participant Acceptability Questionnaire Scales
Time frame: Week 6 (Visit 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29763711Mutz 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.
- Background: PubMed 30917990Mutz 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.
- Background: PubMed 33706656Woodham 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.
- Background: PubMed 35839661Woodham 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.
- Derived from this study: PubMed 40420071Rezaei 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.
- Derived from this study: PubMed 40321750Rezaei 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.
- Derived from this study: PubMed 39162912Ghazi-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Fu, MD, PhD principal investigator
University of East London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Depression, Bipolar and Bipolar Disorder, run by University of East London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436613, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.