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Could a headset at home lift bipolar depression?

NCT ID NCT07556692

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a portable, home-use brain stimulation device (tDCS) can safely reduce depressive symptoms in people with bipolar disorder. 212 adults with bipolar depression will use either the active device or a sham (placebo) version at home for 10 weeks. The goal is to see if this non-invasive, low-current treatment improves mood and is easy to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcranial direct current stimulation (tDCS) device
What this could lead to
If it works, this could offer a safe, at-home option to ease depressive symptoms in bipolar disorder without medication side effects.
What could go wrong
This is a relatively small, early-stage trial. The effect may be small or no better than placebo, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 years or over. 2. 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). 3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979). 4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment. 5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment. 6. Being under care of GP. 7. Agreeable for GP to be regularly informed by research team about participation. 8. Able to provide written, informed consent. Exclusion Criteria: 1. 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). 2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998). 3. Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more. 4. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines). 5. 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). 6. 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. 7. History of esketamine / ketamine for treatment of depression. 8. Medical disorder that may mimic mood disorder (e.g. hormonal disorder). 9. History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues. 10. Have cognitive impairment (e.g. dementia). 11. History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease). 12. History of migraines or intractable headaches. 13. Implant in brain, neurocranial defect or active implantable medical device. 14. Shrapnel or any ferromagnetic material in head. 15. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study 16. Concurrent enrolment in another interventional study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • South London and Maudsley NHS Foundation Trust

    RECRUITING

    London, United Kingdom

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Other studies related to the condition(s) this trial covers.