Abstract
Current treatments for bipolar depression have limited effectiveness, tolerability and acceptability. Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation method that has demonstrated treatment efficacy for major depressive episodes. tDCS is portable, safe, and individuals like having sessions at home. We developed a home-based protocol with real-time remote supervision. In the present study, we have examined the clinical outcomes, acceptability and feasibility of home-based tDCS treatment in bipolar depression. Participants were 44 individuals with bipolar disorder (31 women), mean age 47.27 + 12.89 years, in current depressive episode of moderate to severe severity (mean Montgomery-Åsberg Depression Rating Scale (MADRS) score 24.59 + 2.64). tDCS was provided in a bilateral frontal montage, F3 anode, F4 cathode, 2mA, for 30 minutes, in a 6-week trial, for a total 21 sessions. Participants maintained their current treatment (psychotherapy, antidepressant or mood stabilising medication) or maintained being medication-free. A researcher was present by video call at each session. 93.2% participants (n=41) completed the 6-week treatment. There was a significant improvement in depressive symptoms following treatment (mean MADRS 8.77 + 5.37), the rate of clinical response was 77.3% (MADRS improvement of <=50% from baseline), and the rate of clinical remission was 47.7% (MADRS rating of <=9). Acceptability was endorsed as “very acceptable” or “quite acceptable” by all participants. No participants developed mania or hypomania. Due to the open-label design, efficacy findings are preliminary. In summary, home-based tDCS with real-time supervision was associated with significant clinical improvements and high acceptability in bipolar depression.
Competing Interest Statement
tDCS devices were provided by Flow Neuroscience. Authors AG, RW, HR, MSS, EB, PR and MB do not report any declarations of interest. CF has received grant funding from Milken Institute Baszucki Brain Research (BD00000029), National Institute of Mental Health (R01MH134236), Rosetrees Trust (CF20212104), Flow Neuroscience. Author A.Y. reports the following declaration of interests: Paid lectures and advisory boards for the following companies with drugs used in affective and related disorders: Flow Neuroscience, Novartis, Roche, Janssen, Takeda, Noema pharma, Compass, Astrazenaca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, Sage, Novartis, Neurocentrx. Principal Investigator for the following studies: 1. the Restore-Life VNS registry study funded by LivaNova; 2. ESKETINTRD3004: "An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression"; 3. The Effects of Psilocybin on Cognitive Function in Healthy Participants; 4. The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD); 5. A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy. (Janssen); 6. An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants with Major Depressive Disorder (MDD). (Janssen); 7. A Randomized, Double-blind, Multicentre, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy; 8. A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients with Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNR. (Janssen). UK Chief Investigator for the following studies: 1. Novartis MDD study MIJ821A12201; 2. Compass; COMP006 & COMP007 studies. Grant funding (past and present): NIMH (USA); CIHR (Canada); NARSAD (USA); Stanley Medical Research Institute (USA); MRC (UK); Wellcome Trust (UK); Royal College of Physicians (Edin); BMA (UK); UBC-VGH Foundation (Canada); WEDC (Canada); CCS Depression Research Fund (Canada); MSFHR (Canada); NIHR (UK). Janssen (UK) EU Horizon 2020. Editor of Journal of Psychopharmacology and Deputy Editor, BJPsych Open. No shareholdings in pharmaceutical companies.
Clinical Trial
NCT05436613
Funding Statement
This research was funded by the Milken Institute Baszucki Brain Research Fund (grant number BD-0000000029). The funding source had no involvement in the study design, collection of data, analysis or interpretation of data, writing of the manuscript or in the decision to submit the article for publication.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee of London Fulham Research Ethics Committee gave ethical approval for this work.
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Footnotes
↵* Joint first authors
The author declarations have been updated to include that authors EB and PR do not have any competing interests to declare. Main body of the manuscript updated to remove two spelling typos.
Data Availability
Anonymised data will be made available on request to the corresponding author.