Bipolar Disorder (BD)BDEPNCT07556692
A Study of Home-use Brain Stimulation to Treat Bipolar Depression
A study testing Flow FL-100 tDCS headset in people with Bipolar Disorder (BD), run by King's College London at 1 site in United Kingdom.
Trial summary
Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Flow FL-100 tDCS headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or over.
- Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).
- Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979).
- Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
- Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.
- Being under care of GP.
- Agreeable for GP to be regularly informed by research team about participation.
- Able to provide written, informed consent.
Who cannot join
- Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011).
- Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998).
- Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.
- Current daily use of medications that affect cortical excitability (e.g. benzodiazepines).
- Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of > 8 in Alcohol use disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023).
- History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), other brain stimulation, or psychosurgery for depression.
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- History of esketamine / ketamine for treatment of depression.
- Medical disorder that may mimic mood disorder (e.g. hormonal disorder).
- History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
- Have cognitive impairment (e.g. dementia).
- History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease).
- History of migraines or intractable headaches.
- Implant in brain, neurocranial defect or active implantable medical device.
- Shrapnel or any ferromagnetic material in head.
- If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study
- Concurrent enrolment in another interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
South London and Maudsley NHS Foundation Trust
London
Oluwatofunmi Olaniyan, +44 20 7848 8326, oluwatofunmi.olaniyan@kcl.ac.uk
About this study
Official title: Home-based Transcranial Direct Current Stimulation in Bipolar Depression: a Randomised, Double-blind, Placebo-controlled Trial
Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has shown promise as a treatment for depression. This study aims to find out whether a home-based tDCS device is effective and safe in reducing symptoms of bipolar depression when compared with a placebo (sham) treatment. The study will also look at how acceptable the treatment is to participants and how well people are able to use the device at home.
Who can participate? Adult patients aged 18 years and over who have a diagnosis of bipolar disorder and are currently experiencing a depressive episode.
Read more
What does the study involve? Participants must meet specific eligibility criteria, which will be assessed by the research team. People who do not meet the study criteria or for whom tDCS is not suitable will not be able to take part. Participants will be randomly assigned to receive either active tDCS or a placebo (sham) treatment. Neither the participant nor the researchers assessing outcomes will know which treatment has been assigned.
Participants will use a study device at home over a defined treatment period and will complete a series of assessments at set time points. These include clinician-rated interviews and self-reported questionnaires about mood and well-being. Device use and adherence data will be collected electronically. Participants will also be monitored for any side effects throughout their involvement in the study.
Although the study is multi-site, participation is primarily remote, with most study activities completed from the participant's home.
What are the possible benefits and risks of participating? Participants may experience an improvement in depressive symptoms. Information gained from this study may help improve future treatments for bipolar depression.
tDCS is generally well tolerated. Possible side effects include mild and temporary sensations such as tingling, itching, headache, or skin irritation at the electrode sites. All participants will be monitored for adverse events, and appropriate support will be available if needed.
Where is the study run from? The study is run from King's College London in collaboration with NHS research sites across the UK.
When is the study starting and how long is it expected to run for? April 2026 to October 2027
Who is funding the study? The National Institute for Health and Care Research (NIHR), UK.
Who is the main contact? Professor Cynthia Fu, the Chief Investigator at King's College London, cynthia.fu@kcl.ac.uk
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Flow FL-100 tDCS headset
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow FL-100 tDCS headsetDevice
The Flow FL-100 tDCS device is an adjustable headset with the electrodes built in. It delivers low-intensity direct current through scalp electrodes, modulating cortical excitability in the dorsolateral prefrontal cortex (DLPFC). The device is portable and commercially available.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS + Treatment as Usual | Sham comparator | Not described Receives: Device: Flow FL-100 tDCS headset |
| Active tDCS + Treatment as Usual | Active comparator | Not described Receives: Device: Flow FL-100 tDCS headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine clinical efficacy of a 10-week course of home-based tDCS for bipolar depression in terms of depressive symptoms as measured by clinician-rated MADRS score in active and sham treatment arms at week 10
Measured: From randomisation to the end of treatment at 10 weeks
Secondary outcomes (9)
To assess effects in self-rated depressive symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Quick Inventory of Depressive Symptomatology (QIDS-SR)
Measured: From randomisation to the end of treatment at 10 weeks
To assess effects in clinician-rated anxiety symptoms following 10-week course of home based tDCS between active and sham treatment arms as measured by Hamilton Anxiety Rating Scale (HAMA)
Measured: From randomisation to the end of treatment at 10 weeks
To assess effects in self-rated anxiety symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Generalized Anxiety Disorder questionnaire (GAD-7)
Measured: From randomisation to the end of treatment at 10 weeks
To assess effects in self-rated quality of life following 10-week course of home-based tDCS between active and sham treatment arms as measured by EQ-5D-5L questionnaire
Measured: From randomisation to the end of treatment at 10 weeks
To assess effects in clinician-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by clinician-rated MADRS
Measured: 6 months post randomisation
To assess effects in self-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by QIDS-SR
Measured: 6 months post randomisation
To assess effects in clinician-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by HAMA
Measured: 6 months post randomisation
To assess effects in self-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by GAD-7
Measured: 6 months post randomisation
To assess effects in quality of life at 6-month follow up between active and sham treatment arms as measured by EQ-5D-5L
Measured: 6 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start24 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556692
- Sponsor's protocol ID
- IRAS 348113
- Other IDs
- NIHR167361
- Acronym
- BDEP
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data and the data dictionary will be made available on request to academic researchers. The Statistical Analysis Plan is available in the Supplementary Materials. A data request and brief analysis plan will be required in accordance with Ethics Committee requirements. These will be reviewed by the lead, study steering committee and study sponsor. A data transfer agreement (DTA) will have to be completed prior to any data being shared. Following completion of the DTA, data will be shared as password-protected files. Data sharing will abide by the rules and policies defined by the sponsor, relevant institutional review boards, and local, state and federal laws and regulations. Rights and privacy of individuals participating in the research will be protected at all times. Approval will not be provided for commercial use of the data.
Publications
Lagerberg PJ, Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Rizvi M, Kwon SS, Orhii P, Machado-Vieira R, Soares JC, Young AH, Fidalgo AR, Rezaei H, Fu CHY. Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial. Ann Gen Psychiatry. 2025 Dec 4;25(1):1. doi: 10.1186/s12991-025-00607-4.
PubMed 41345653Rezaei 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 40420071Ghazi-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 39162912Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation for major depressive disorder: 6-month follow-up from randomised sham-controlled trial and open-label treatment phases. J Psychiatr Res. 2025 Jun;186:23-32. doi: 10.1016/j.jpsychires.2025.03.047. Epub 2025 Mar 26.
PubMed 40209536Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
PubMed 39433921Woodham 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 35839661
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation in Bipolar Depression: a Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07556692
- Acronym / sponsor ID
- BDEP / IRAS 348113
- Conditions
- Bipolar Disorder (BD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 24 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has shown promise as a treatment for depression. This study aims to find out whether a home-based tDCS device is effective and safe in reducing symptoms of bipolar depression when compared with a placebo (sham) treatment. The study will also look at how acceptable the treatment is to participants and how well people are able to use the device at home.
Who can participate? Adult patients aged 18 years and over who have a diagnosis of bipolar disorder and are currently experiencing a depressive episode.
What does the study involve? Participants must meet specific eligibility criteria, which will be assessed by the research team. People who do not meet the study criteria or for whom tDCS is not suitable will not be able to take part. Participants will be randomly assigned to receive either active tDCS or a placebo (sham) treatment. Neither the participant nor the researchers assessing outcomes will know which treatment has been assigned.
Participants will use a study device at home over a defined treatment period and will complete a series of assessments at set time points. These include clinician-rated interviews and self-reported questionnaires about mood and well-being. Device use and adherence data will be collected electronically. Participants will also be monitored for any side effects throughout their involvement in the study.
Although the study is multi-site, participation is primarily remote, with most study activities completed from the participant's home.
What are the possible benefits and risks of participating? Participants may experience an improvement in depressive symptoms. Information gained from this study may help improve future treatments for bipolar depression.
tDCS is generally well tolerated. Possible side effects include mild and temporary sensations such as tingling, itching, headache, or skin irritation at the electrode sites. All participants will be monitored for adverse events, and appropriate support will be available if needed.
Where is the study run from? The study is run from King's College London in collaboration with NHS research sites across the UK.
When is the study starting and how long is it expected to run for? April 2026 to October 2027
Who is funding the study? The National Institute for Health and Care Research (NIHR), UK.
Who is the main contact? Professor Cynthia Fu, the Chief Investigator at King's College London, cynthia.fu@kcl.ac.uk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS + Treatment as Usual | Sham comparator | Device: Flow FL-100 tDCS headset |
| Active tDCS + Treatment as Usual | Active comparator | Device: Flow FL-100 tDCS headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or over.
- Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).
- Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979).
- Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
- Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.
Key exclusion criteria (16 listed)
- Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011).
- Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998).
- Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.
- Current daily use of medications that affect cortical excitability (e.g. benzodiazepines).
- Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of > 8 in Alcohol use disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023).
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 |
|---|---|---|
| Flow FL-100 tDCS headsetThe Flow FL-100 tDCS device is an adjustable headset with the electrodes built in. It delivers low-intensity direct current through scalp electrodes, modulating cortical excitability in the dorsolateral prefrontal cortex (DLPFC). The device is portable and commercially available. | Device | Active tDCS + Treatment as Usual, Sham tDCS + Treatment as Usual |
Primary outcome
To determine clinical efficacy of a 10-week course of home-based tDCS for bipolar depression in terms of depressive symptoms as measured by clinician-rated MADRS score in active and sham treatment arms at week 10
Time frame: From randomisation to the end of treatment at 10 weeks
9 secondary outcomes
To assess effects in self-rated depressive symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Quick Inventory of Depressive Symptomatology (QIDS-SR)
Time frame: From randomisation to the end of treatment at 10 weeks
To assess effects in clinician-rated anxiety symptoms following 10-week course of home based tDCS between active and sham treatment arms as measured by Hamilton Anxiety Rating Scale (HAMA)
Time frame: From randomisation to the end of treatment at 10 weeks
To assess effects in self-rated anxiety symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Generalized Anxiety Disorder questionnaire (GAD-7)
Time frame: From randomisation to the end of treatment at 10 weeks
To assess effects in self-rated quality of life following 10-week course of home-based tDCS between active and sham treatment arms as measured by EQ-5D-5L questionnaire
Time frame: From randomisation to the end of treatment at 10 weeks
To assess effects in clinician-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by clinician-rated MADRS
Time frame: 6 months post randomisation
To assess effects in self-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by QIDS-SR
Time frame: 6 months post randomisation
To assess effects in clinician-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by HAMA
Time frame: 6 months post randomisation
To assess effects in self-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by GAD-7
Time frame: 6 months post randomisation
To assess effects in quality of life at 6-month follow up between active and sham treatment arms as measured by EQ-5D-5L
Time frame: 6 months post randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 41345653Lagerberg PJ, Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Rizvi M, Kwon SS, Orhii P, Machado-Vieira R, Soares JC, Young AH, Fidalgo AR, Rezaei H, Fu CHY. Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial. Ann Gen Psychiatry. 2025 Dec 4;25(1):1. doi: 10.1186/s12991-025-00607-4.
- Background: 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.
- Background: 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.
- Background: PubMed 40209536Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation for major depressive disorder: 6-month follow-up from randomised sham-controlled trial and open-label treatment phases. J Psychiatr Res. 2025 Jun;186:23-32. doi: 10.1016/j.jpsychires.2025.03.047. Epub 2025 Mar 26.
- Background: PubMed 39433921Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
- 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data and the data dictionary will be made available on request to academic researchers. The Statistical Analysis Plan is available in the Supplementary Materials. A data request and brief analysis plan will be required in accordance with Ethics Committee requirements. These will be reviewed by the lead, study steering committee and study sponsor. A data transfer agreement (DTA) will have to be completed prior to any data being shared. Following completion of the DTA, data will be shared as password-protected files. Data sharing will abide by the rules and policies defined by the sponsor, relevant institutional review boards, and local, state and federal laws and regulations. Rights and privacy of individuals participating in the research will be protected at all times. Approval will not be provided for commercial use of the data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow FL-100 tDCS headset in people with Bipolar Disorder (BD), run by King's College 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Cynthia Fu (0207848832, cynthia.fu@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine clinical efficacy of a 10-week course of home-based tDCS for bipolar depression in terms of depressive symptoms as measured by clinician-rated MADRS score in active and sham treatment arms at week 10 (time frame: From randomisation to the end of treatment at 10 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 NCT07556692, which also lists 6 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 29 Apr 2026.