Bipolar Disorder
Conditions
Interventions
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 addi
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
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-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy, based on depressive symptoms measured using the Montgomery–Åsberg Depression Rating Scale (MADRS) score at baseline and week 10-post intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-rated depressive symptoms measured using Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR) at baseline, and weeks 1, 4, 7, and 10 (post-intervention), and the 4- and 6-month follow-ups;Clinician-rated anxiety symptoms measured using Hamilton Anxiety Rating Scale (HAMA) at baseline, and weeks 1, 4, 7, and 10 (post-intervention), and the 4- and 6-month follow-ups;Self-rated anxiety symptoms measured using Generalized Anxiety Disorder 7-item questionnaire (GAD-7) at baseline, and weeks 1, 4, 7, and 10 (post-intervention), and the 4- and 6-month follow-ups;Quality of life measured using EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline, and weeks 1, 4, 7, and 10 (post-intervention), and the 4- and 6-month follow-ups;Clinician-rated depressive symptoms (6-month outcome) measured using Montgomery–Åsberg Depression Rating Scale (MADRS) at baseline and 6-month follow-up;Self-rated depressive symptoms (6-month outcome) measured using Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR) at baseline and 6-month follow-up;Clinician-rated anxiety symptoms (6-month outcome) measured using Hamilton Anxiety Rating Scale (HAMA) at baseline and 6-month follow-up;Self-rated anxiety symptoms (6-month outcome) measured using Generalized Anxiety Disorder 7-item questionnaire (GAD-7) at baseline and 6-month follow-up;Quality of life (6-month outcome) measured using EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) at baseline and 6-month follow-up | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactLingfeng Xue
Outcome results
None listed