Could a headset at home lift bipolar depression?
NCT ID NCT07556692
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
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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
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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South London and Maudsley NHS Foundation Trust
RECRUITINGLondon, United Kingdom
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