About BDEP

Summary

BDEP is double-blind, multi-centre, two-parallel group, superiority randomised controlled trial to evaluate home-based transcranial direct current stimulation in bipolar depression.

The primary outcome is to evaluate tDCS clinical efficacy as the difference in depressive symptom severity at end of 10-week treatment period between active and sham treatment allocation arms.

The study is sponsored by King’s College London and co-sponsored by South London and Maudsley NHS Foundation Trust.

The study is funded by the National Institute for Health and Care Research (NIHR) (REF:NIHR167361). London - Dulwich Research Ethics Committee (IRAS ID: 348113).

Trial Information

REC Reference: 26/LO/0035

IRAS: 348113 

Sponsor: King’s College London

Co-Sponsor: South London and Maudsley NHS Foundation Trust

Funder: National Institute for Health and Care Research (NIHR) 

Enrolment: 212

Study Population

Inclusion Criteria

  • Adults aged 18 years or over

  • 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)

  • Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979)

  • Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.

  • Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.

  • Being under care of GP

  • Agreeable for GP to be regularly informed by research team about participation

  • Able to provide written, informed consent

Exclusion Criteria

  • 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)

  • Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM-5 criteria as assessed in MINI (Sheehan et al., 1998)

  • Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.

  • Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)

  • 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)

  • 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

  • History of esketamine / ketamine for treatment of depression

  • Medical disorder that may mimic mood disorder (e.g. hormonal disorder)

  • History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues

  • Have cognitive impairment (e.g. dementia)

  • History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease)

  • History of migraines or intractable headaches

  • Implant in brain, neurocranial defect or active implantable medical device

  • Shrapnel or any ferromagnetic material in head

  • If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study

  • Concurrent enrolment in another interventional study 

Study Arms

Eligible participants will be randomised to one of two parallel groups: sham-control treatment arm: treatment as usual (TAU) + sham tDCS or active treatment arm: TAU + active tDCS. Allocation is concealed from participants, investigators, outcome assessors, data managers and statisticians. The tDCS devices are identical in appearance, ensuring maintenance of the blind.

Primary Objective

To determine clinical efficacy of a 10-week course of home-based tDCS for bipolar depression in terms of depressive symptoms as measured by clinician-rated MADRS score in active and sham treatment arms at week 10.

Secondary Objectives

  1. To assess effects in self-rated depressive symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Quick Inventory of Depressive Symptomatology (QIDS-SR)

  2. To assess effects in clinician-rated anxiety symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Hamilton Anxiety Rating Scale (HAMA)

  3. To assess effects in self-rated anxiety symptoms following 10-week course of home-based tDCS between active and sham treatment arms as measured by Generalized Anxiety Disorder questionnaire (GAD-7)

  4. To assess effects in self-rated quality of life following 10-week course of home-based tDCS between active and sham treatment arms as measured by EQ-5D-5L questionnaire

  5. To assess effects in clinician-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by clinician-rated MADRS

  6. To assess effects in self-rated depressive symptoms at 6-month follow up between active and sham treatment arms as measured by QIDS-SR

  7. To assess effects in clinician-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by HAMA

  8. To assess effects in self-rated anxiety symptoms at 6-month follow up between active and sham treatment arms as measured by GAD-7

  9. To assess effects in quality of life at 6-month follow up between active and sham treatment arms as measured by EQ-5D-5L