Home-use brain stimulation for bipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a controlled study comparing active transcranial direct current stimulation (tDCS) delivered with the Flow FL-100 headset to a placebo (sham) version of the device used at home. Adult participants with DSM-5 bipolar disorder who are currently in a depressive episode and meet a minimum severity threshold (MADRS ≥18) are eligible after structured clinical assessment. The study will measure changes in depressive symptoms, monitor safety, and record how acceptable and usable the home device is for participants. Researchers will require informed consent and regular communication with participants' GPs as part of the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• South London and Maudsley NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Professor Cynthia Fu
• Email: cynthia.fu@kcl.ac.uk
• Phone: 0207848832

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Affective Cognitive Training for mood disorders and their close relatives

  A six-week program combining virtual reality and computer exercises tests whether affective cognitive training helps people with mood disorders and their unaffected first-degree relatives.

  Recruiting Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Frederiksberg, Capital Region of Denmark · NCT07920302

• Understanding anxiety, depression, and bipolar disorder over time in China

  This study tests how anxiety, depressive, and bipolar symptoms change over three years to find patterns that help with earlier recognition and prediction in people aged 12–55.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07903246

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Customized brain stimulation to help mood in bipolar disorder

  This study tests whether personalized, non-invasive brain stimulation with rTMS can help people with bipolar depression see if their mood shifts toward euthymia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07680153

• Pramipexole adds on to mood stabilizers for bipolar depression

  This trial tests whether adding pramipexole to standard mood-stabilizing treatment helps reduce anhedonia in adults with bipolar depression compared to a placebo.

  Recruiting Phase 3 Region Skane · Lund, Skåne County · NCT07664852

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.