A simple headset that delivers a weak electrical current to the brain could lift people with bipolar disorder out of depression, without the side effects of medication. Around one million people in the UK have bipolar disorder, yet treatment options remain limited. Standard care—a mix of mood stabilisers, antipsychotics, and antidepressants—often causes side effects and works poorly for many patients. During the pandemic, the risk of a depressive episode in bipolar disorder was four times higher than in other mental health conditions. This trial tests whether transcranial direct current stimulation (tDCS), a portable, self-administered device, can fill that gap. If the trial succeeds, patients could have a new, drug-free option for managing bipolar depression within five years. The device is used at home, reducing the need for hospital visits and aligning with the NHS Long Term Plan to shift care out of hospitals and into the community. For the roughly 212 participants, the treatment involves 36 sessions over ten weeks, with a six-month follow-up to check lasting effects. If proven effective, tDCS could become a routine part of NHS mental health care, offering a safe, acceptable alternative to those who cannot tolerate existing drugs.
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Research question: What is the clinical efficacy of home-based tDCS treatment for bipolar depression? Background: Bipolar disorder is severe and debilitating. About 1 million people in the UK have bipolar disorder, yet, it is an overlooked disorder. During the Covid-19 pandemic, the highest risk of developing a depressive episode was in bipolar disorder, which was four times greater than other mental health disorders. Current treatments are typically a combination of antipsychotic medication or mood stabiliser with an antidepressant, but they have side effects as well as limited effectiveness, tolerability and acceptability. Our patient and public involvement members emphasize the pressing need for novel treatment options that are effective, safe and acceptable. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that modulates cortical tissue excitability. tDCS is portable and can be self-administered. In our home-base pilot study, we found high acceptability, safety, and strong treatment outcomes. Aims and Objectives: Aims are to assess clinical efficacy and safety of home-based tDCS treatment for bipolar depression. Primary objective is to evaluate clinical efficacy as difference in depressive symptoms at 10-week end of treatment between two treatment arms: active tDCS plus treatment as usual (TAU) and sham tDCS plus TAU as measured by clinician-rated Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary objectives include efficacy in self-reported mood, anxiety and quality of life at end of treatment and longer term at 6 months. Process evaluation will assess adherence, safety and fidelity. Methods: Multi-centre, two-parallel group, superiority randomised controlled trial (RCT). Study population is participants with bipolar disorder in current depressive episode, based on DSM-5 criteria by structured clinical interview, and having at least a moderate severity of depressive symptoms, measured by MADRS rating of a minimum of 18. Sample size is 212 participants with bipolar depression. Randomised treatment allocation to: active tDCS+TAU or sham tDCS+TAU. tDCS device is headset with anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4). tDCS sessions are 5 sessions per week for 3 weeks then 3 sessions per week for 7 weeks, total of 36 sessions. Active tDCS stimulation is 2 mA for 30 minutes per session. Sham tDCS stimulation is 0 mA with a brief ramp up and ramp down at the start and end of each session to mimic active stimulation. TAU standard care can be mood stabilising medication and/or antidepressant medication and/or psychotherapy or treatment-free. Trial consists of initial blinded phase: 10-week treatment protocol with 6-month follow up, followed by open label phase after 6 months: all participants have option for active tDCS treatment in 9-month follow up. Timelines for delivery: If efficacy is demonstrated, treatment option could be available within 5 years in day-to-day care. Anticipated impact and dissemination: Research addresses an unmet need for more effective treatment options for bipolar depression, which will benefit individuals with bipolar disorder and improve NHS care pathways. Research addresses NHS Long Term Plan to boost 'out-of-hospital' care with integration into primary and community mental health care. Dissemination will be through academic publications, social media and stakeholder events.
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