Efficacy and Safety of Daily Home-based Transcranial Direct Current Stimulation As Adjunct Treatment for Bipolar Depressive Episodes: Double-blind Sham-controlled Randomized Clinical Trial

Overview

Journal Front Psychiatry

Specialty Psychiatry

Date 2022 Oct 7

PMID 36203828

Authors

Jangwon Lee

Chan Woo Lee

Yoonjeong Jang

Ji Seon You

Yun Seong Park

Eunjeong Ji

Hyeona Yu

Sunghee Oh

Hyun A Ryoo

Nayoung Cho

Ji Yoon Park

Joohyun Yoon

Ji Hyun Baek

Hye Youn Park

Tae Hyon Ha

Woojae Myung

Affiliations

Soon will be listed here.

Abstract

Background: Although transcranial direct current stimulation (tDCS) is known to be a promising therapeutic modality for unipolar depression, the efficacy and safety of tDCS for bipolar depressive episodes (BD) are still unknown and clinical trials of home-based tDCS treatment are scarce. As a result, we set out to investigate the efficacy and safety of home-based tDCS for the treatment BD.

Methods: Participants ( = 64), diagnosed as bipolar disorder as per the diagnostic and statistical manual of mental disorders (DSM-5), were randomly assigned to receive tDCS. Hamilton Depression Rating Scale (HDRS-17) scores were measured at the baseline, week 2, 4, and 6, and home-based tDCS (for 30 min with 2 mA) was self-administered daily.

Results: Of the 64 patients (15.6% bipolar disorder I, 84.4% bipolar disorder II), 41 patients completed the entire assessment. In the intention-to-treat analysis, time-group interaction for the HDRS-17 [ = 2.060; = 0.108] and adverse effect differences between two groups were not statistically significant, except the pain score, which was higher in the active group than the sham group (week 0-2: < 0.01, week 2-4: < 0.05, and week 4-6: < 0.01).

Conclusion: Even though we found no evidence for the efficacy of home-based tDCS for patients with BD, this tool was found to be a safe and tolerable treatment modality for BD.

Clinical Trial Registration: [https://clinicaltrials.gov/show/NCT03974815], identifier [NCT03974815].

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References

Judd L, Akiskal H, Schettler P, Endicott J, Maser J, Solomon D . The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002; 59(6):530-7. DOI: 10.1001/archpsyc.59.6.530. View

Galvez V, Alonzo A, Martin D, Mitchell P, Sachdev P, Loo C . Hypomania induction in a patient with bipolar II disorder by transcranial direct current stimulation (tDCS). J ECT. 2011; 27(3):256-8. DOI: 10.1097/YCT.0b013e3182012b89. View

Goodwin G, Haddad P, Ferrier I, Aronson J, Barnes T, Cipriani A . Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2016; 30(6):495-553. PMC: 4922419. DOI: 10.1177/0269881116636545. View

Baldessarini R, Vazquez G, Tondo L . Bipolar depression: a major unsolved challenge. Int J Bipolar Disord. 2020; 8(1):1. PMC: 6943098. DOI: 10.1186/s40345-019-0160-1. View

Lees G, Leach M . Studies on the mechanism of action of the novel anticonvulsant lamotrigine (Lamictal) using primary neurological cultures from rat cortex. Brain Res. 1993; 612(1-2):190-9. DOI: 10.1016/0006-8993(93)91660-k. View

Guarienti F, Caumo W, Shiozawa P, Cordeiro Q, Boggio P, Bensenor I . Reducing transcranial direct current stimulation-induced erythema with skin pretreatment: considerations for sham-controlled clinical trials. Neuromodulation. 2014; 18(4):261-5. DOI: 10.1111/ner.12230. View

Brunoni A, Ferrucci R, Bortolomasi M, Scelzo E, Boggio P, Fregni F . Interactions between transcranial direct current stimulation (tDCS) and pharmacological interventions in the Major Depressive Episode: findings from a naturalistic study. Eur Psychiatry. 2012; 28(6):356-61. DOI: 10.1016/j.eurpsy.2012.09.001. View

Sheehan D, Lecrubier Y, Sheehan K, Amorim P, Janavs J, Weiller E . The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1999; 59 Suppl 20:22-33;quiz 34-57. View

Lauro L, Rosanova M, Mattavelli G, Convento S, Pisoni A, Opitz A . TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014; 58:99-111. DOI: 10.1016/j.cortex.2014.05.003. View

10.

DellOsso B, Zanoni S, Ferrucci R, Vergari M, Castellano F, DUrso N . Transcranial direct current stimulation for the outpatient treatment of poor-responder depressed patients. Eur Psychiatry. 2011; 27(7):513-7. DOI: 10.1016/j.eurpsy.2011.02.008. View

11.

Yatham L, Kennedy S, Parikh S, Schaffer A, Bond D, Frey B . Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018; 20(2):97-170. PMC: 5947163. DOI: 10.1111/bdi.12609. View

12.

Brunoni A, Amadera J, Berbel B, Volz M, Rizzerio B, Fregni F . A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011; 14(8):1133-45. DOI: 10.1017/S1461145710001690. View

13.

Brunoni A, Moffa A, Fregni F, Palm U, Padberg F, Blumberger D . Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016; 208(6):522-31. PMC: 4887722. DOI: 10.1192/bjp.bp.115.164715. View

14.

Grunze H, Vieta E, Goodwin G, Bowden C, Licht R, Moller H . The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2013; 14(3):154-219. DOI: 10.3109/15622975.2013.770551. View

15.

George M, Taylor J, Short E . The expanding evidence base for rTMS treatment of depression. Curr Opin Psychiatry. 2012; 26(1):13-8. PMC: 4214363. DOI: 10.1097/YCO.0b013e32835ab46d. View

16.

De Smet S, Nikolin S, Moffa A, Suen P, Vanderhasselt M, Brunoni A . Determinants of sham response in tDCS depression trials: a systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021; 109:110261. DOI: 10.1016/j.pnpbp.2021.110261. View

17.

Charvet L, Kasschau M, Datta A, Knotkova H, Stevens M, Alonzo A . Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols. Front Syst Neurosci. 2015; 9:26. PMC: 4362220. DOI: 10.3389/fnsys.2015.00026. View

18.

Tortella G, Casati R, Aparicio L, Mantovani A, Senco N, DUrso G . Transcranial direct current stimulation in psychiatric disorders. World J Psychiatry. 2015; 5(1):88-102. PMC: 4369553. DOI: 10.5498/wjp.v5.i1.88. View

19.

Young R, Biggs J, Ziegler V, Meyer D . A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978; 133:429-35. DOI: 10.1192/bjp.133.5.429. View

20.

Bourin M, Chenu F, Hascoet M . The role of sodium channels in the mechanism of action of antidepressants and mood stabilizers. Curr Drug Targets. 2009; 10(11):1052-60. DOI: 10.2174/138945009789735138. View