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

Abstract

BackgroundAlthough 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.MethodsParticipants (n = 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.ResultsOf 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 [F(3, 146.36) = 2.060; p = 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: p < 0.01, week 2–4: p < 0.05, and week 4–6: p < 0.01).ConclusionEven 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].

A Review of Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation Combined with Medication and Psychotherapy for Depression

“…Although, for one of the studies (n = 30), these differences were not maintained at three-month follow-up 75 . Two randomized controlled trials (n = 41) did not find statistically significant group differences (n = 41), with one (n = 160) specifically finding a negative result with stable doses of ongoing SSRIs 77,78 . The three open-label studies found that adding tDCS to stable ongoing medications was associated with MDD symptom reductions of 18% to 34.1%, with an average 25% reduction 79-81 .…”

“…There are fewer studies (nine) exploring tDCS with medication compared to the 32 TMS and medication studies. The majority of the tDCS plus medication studies (six) investigated stable doses of ongoing medications plus tDCS 72,75-77,79,81 . Five out of six suggest that tDCS plus continual medications is superior to the medications by themselves or linked to MDD symptom reduction.…”

“…75 Two randomized controlled trials (n = 41) did not find statistically significant group differences (n = 41), with one (n = 160) specifically finding a negative result with stable doses of ongoing SSRIs. 77,78 The three open-label studies found that adding tDCS to stable ongoing medications was associated with MDD symptom reductions of 18% to 34.1%, with an average 25% reduction. [79][80][81] Two studies found that stable ongoing dosages of benzodiazepines predicted worse outcomes.…”

“…The majority of the tDCS plus medication studies (six) investigated stable doses of ongoing medications plus tDCS. 72,[75][76][77]79,81 Five out of six suggest that tDCS plus continual medications is superior to the medications by themselves or linked to MDD symptom reduction. The majority have also utilized similar stimulation protocols, with the anode over left dlPFC and cathode over right dlPFC at 2 mA for 20 minutes, with 10 or 20 overall sessions.…”

Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events

“…In bipolar depression, Lee et al (2022) recently reported an RCT of daily home-based active or sham tDCS as an adjunct treatment to mood-stabilising medication . No significant differences in depressive symptoms were found between groups after 6-weeks of treatment.…”