Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial

Burkhardt, Gerrit; Kumpf, Ulrike; Crispin, Alexander; Goerigk, Stephan; André, Elisabeth; Plewnia, Christian; Brendel, Bettina; Fallgatter, Andreas J.; Langguth, Berthold; Abdelnaim, Mohamed A.; Hebel, Tobias; Normann, Claus; Frase, Lukas; Zwanzger, Peter; Diemer, Julia; Kammer, Thomas; Schönfeldt‐Lecuona, Carlos; Kamp, Daniel; Bajbouj, Malek; Behler, Nora; Wilkening, Anja; Nenov-Matt, Tabea; Dechantsreiter, Esther; Keeser, Daniel; Bulubas, Lucia; Palm, Ulrich; Blankenstein, Christiane; Mansmann, Ulrich; Falkai, Peter; Brunoni, André R.; Hasan, Alkomiet; Padberg, Frank

doi:10.1016/s0140-6736(23)00640-2

Cited by 21 publications

(19 citation statements)

References 24 publications

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“…Although the home-based setting could theoretically have diminished the placebo response, as patients did not visit the clinical center on a daily basis, our results were similar to recent on-site tDCS trials in depression . Interestingly, in a recent consensus statement, specialists did not agree on whether the placebo response would be larger in digital trials .…”

Section: Discussionsupporting

confidence: 67%

“…For instance, in our previous noninferiority randomized trial comparing on-site tDCS with escitalopram, treatment with tDCS was superior to sham only after the sixth week of treatment . Also, a recent trial that investigated the additive effects of on-site tDCS in patients with depression receiving stable pharmacotherapy showed no difference between active and sham tDCS, but also lasted only 6 weeks …”

Section: Discussionmentioning

confidence: 99%

“…A 6-week treatment course might have been too short to induce clinical effects. This time frame was also used in 2 large-scale tDCS randomized clinical trials that yielded negative results, while significant tDCS effects were observed in a study that spanned 22 tDCS sessions over 10 weeks . Also, a recent meta-analysis suggested that tDCS might display larger antidepressant effects over longer treatment courses.…”

Section: Discussionmentioning

confidence: 99%

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Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Borrione,

Cavendish,

Aparicio

et al. 2024

JAMA Psychiatry

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ImportanceTranscranial direct current stimulation (tDCS) is moderately effective for depression when applied by trained staff. It is not known whether self-applied tDCS, combined or not with a digital psychological intervention, is also effective.ObjectiveTo determine whether fully unsupervised home-use tDCS, combined with a digital psychological intervention or digital placebo, is effective for a major depressive episode.Design, Setting, and ParticipantsThis was a double-blinded, sham-controlled, randomized clinical trial with 3 arms: (1) home-use tDCS plus a digital psychological intervention (double active); (2) home-use tDCS plus digital placebo (tDCS only), and (3) sham home-use tDCS plus digital placebo (double sham). The study was conducted between April 2021 and October 2022 at participants’ homes and at Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. Included participants were aged 18 to 59 years with major depression and a Hamilton Depression Rating Scale, 17-item version (HDRS-17), score above 16, a minimum of 8 years of education, and access to a smartphone and internet at home. Exclusion criteria were other psychiatric disorders, except for anxiety; neurologic or clinical disorders; and tDCS contraindications.InterventionstDCS was administered in 2-mA, 30-minute prefrontal sessions for 15 consecutive weekdays (1-mA, 90-second duration for sham) and twice-weekly sessions for 3 weeks. The digital intervention consisted of 46 sessions based on behavioral therapy. Digital placebo was internet browsing.Main Outcomes and MeasuresChange in HDRS-17 score at week 6.ResultsOf 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n = 64), tDCS only (n = 73), or double sham (n = 73). Of the 210 participants enrolled, 199 finished the trial. Linear mixed-effects models did not reveal statistically significant group differences in treatment by time interactions for HDRS-17 scores, and the estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, −0.48 to 0.58; P = .86), double active vs double sham (Cohen d, −0.20; 95% CI, −0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, −0.25; 95% CI, −0.76 to 0.27; P = .35). Skin redness and heat or burning sensations were more frequent in the double active and tDCS only groups. One nonfatal suicide attempt occurred in the tDCS only group.Conclusions and RelevanceUnsupervised home-use tDCS combined with a digital psychological intervention or digital placebo was not found to be superior to sham for treatment of a major depressive episode in this trial.Trial RegistrationClinicalTrials.gov Identifier: NCT04889976

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Section: Discussionsupporting

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Borrione,

Cavendish,

Aparicio

et al. 2024

JAMA Psychiatry

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“…27 The findings support clinic-based studies, in which active tDCS shows greater efficacy than sham tDCS in MDD, particularly in first episode and recurrent MDD. 5,[28][29][30] In a recent large trial though, Bukhardt et al 31 did not observe any significant effects in a 6-week trial of adjunctive tDCS treatment to antidepressant medication. However, the trial had included participants with a history of poor treatment response to multiple antidepressant medications, and treatment resistant depression is negatively correlated with clinical efficacy 5,[28][29][30] .…”

Section: Discussionmentioning

confidence: 96%

Home-based transcranial direct current stimulation RCT in major depression

Woodham,

Selvaraj,

Lajmi

et al. 2023

Preprint

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Background Transcranial direct current stimulation (tDCS) has been proposed as a novel treatment in major depressive disorder (MDD). However, efficacy and safety of home-based tDCS treatment have not been investigated. Methods Fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of home-based tDCS treatment in MDD was conducted in UK and USA. Participants were adults 18 years or older, having MDD diagnosis based on DSM-5 criteria, in current depressive episode of at least moderate severity, measured by score >=16 on 17-item Hamilton Depression Rating Scale (HDRS), without treatment resistant depression history. Protocol was 10-week blinded phase: 5 tDCS sessions per week for 3 weeks then 3 sessions per week for 7 weeks; followed by 10-week open label phase. tDCS montage was bifrontal, 30-minute sessions, active tDCS 2 mA, and sham tDCS 0 mA with brief ramp up and down to mimic active device. Primary outcome was HDRS change at week 10 in modified intention-to-treat analysis. Results 174 MDD participants were randomized: active (n=87; mean age 37.1 + 11.1 years) and sham (n=87; mean age 38.3 + 10.9 years) treatment. Significant improvement in HDRS was observed in active (9.4 + 6.25 points) relative to sham treatment (7.1 + 6.10 points) (95% CI 0.5 to 4.0, p = 0.012), with no differences in discontinuation rates between active (n=13) and sham (n=12). Conclusions Home-based tDCS with remote supervision is a potential first line treatment for MDD that is acceptable and safe. Consideration of continuing effective safety monitoring is required. Trial registration numberNCT05202119

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“…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 .…”

Section: Resultsmentioning

confidence: 95%

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

Kochanowski,

Kageki-Bonnert,

Pinkerton

et al. 2024

Harv Rev Psychiatry

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Learning Objectives After participating in this CME activity, the psychiatrist should be better able to: • Compare and contrast therapies used in combination with transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) for treating MDD. Background Noninvasive neuromodulation, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has emerged as a major area for treating major depressive disorder (MDD). This review has two primary aims: (1) to review the current literature on combining TMS and tDCS with other therapies, such as psychotherapy and psychopharmacological interventions, and (2) to discuss the efficacy, feasibility, limitations, and future directions of these combined treatments for MDD. Method This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched three databases: PubMed, PsycInfo, and Cochrane Library. The last search date was December 5, 2023. Results The initial search revealed 2,519 records. After screening and full-text review, 58 studies (7 TMS plus psychotherapy, 32 TMS plus medication, 7 tDCS plus psychotherapy, 12 tDCS plus medication) were included. Conclusions The current literature on tDCS and TMS paired with psychotherapy provides initial support for integrating mindfulness interventions with both TMS and tDCS. Adding TMS or tDCS to stable doses of ongoing medications can decrease MDD symptoms; however, benzodiazepines may interfere with TMS and tDCS response, and antipsychotics can interfere with TMS response. Pairing citalopram with TMS and sertraline with tDCS can lead to greater MDD symptom reduction compared to using these medications alone. Future studies need to enroll larger samples, include randomized controlled study designs, create more uniform protocols for combined treatment delivery, and explore mechanisms and predictors of change.

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Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial

Cited by 21 publications

References 24 publications

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Home-based transcranial direct current stimulation RCT in major depression

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

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