Home-based transcranial direct current stimulation in bipolar depression: a randomised, double-blind, placebo-controlled trial
Bipolar Disorder; Mental health
Randomisation: Following confirmation of eligibility to participate in the trial, written consent and baseline assessment, participants will be randomly allocated to receive either active tDCS in addition to treatment as usual (active treatment arm) or sham tDCS in addition to treatment as usual (sham treatment arm) in a 1:1 ratio. Randomisation will be at the participant level, stratified by recruitment site, using randomly varying block sizes within the site. Randomisation will be implemented via an online system provided by King's College London (KCL) Clinical Trial Unit (KCTU). This bespoke randomisation system will be created in collaboration with the trial analyst/s and the Cl and maintained by the King's Clinical Trials Unit for the duration of the project. It will be hosted on a dedicated server within KCL. Randomisation will be at the level of the individual, and the system will employ block randomisation with randomly varying block sizes and will be stratified by site. The details needed for randomisation (study site, date of birth (dd/mm/yyyy), initials and unique patient identity number)) will be held in a dedicated database. Research assistants, senior trial manager, project coordinator, Pls and CI will have access to the randomisation system. Randomisation will be undertaken by research assistants, senior trial manager, project coordinator and Cl onto the randomisation system by going to www.ctu.co.uk and clicking the link to access the randomisation system. A full audit trail of data entry will be automatically date and time-stamped, alongside information about the user making the entry within the system. Research assistants will have access to randomise participants at the research site where they are based. Research assistants at KCL, senior trial manager, project coordinator and Cl will have access to randomise participants at all research sites. Treatment arm allocation data will be automatically sent to the tDCS device manufacturer, and this i
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.
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-5 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.