Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression: A Randomized Clinical Trial.

Abstract

Importance:

More effective, tolerable interventions for bipolar depression treatment are needed. Transcranial direct current stimulation (tDCS) is a novel therapeutic modality with few severe adverse events that showed promising results for unipolar depression.

Objective:

To determine the efficacy and safety of tDCS as an add-on treatment for bipolar depression.

Design, Setting, and Participants:

A randomized, sham-controlled, double-blind trial (the Bipolar Depression Electrical Treatment Trial [BETTER]) was conducted from July 1, 2014, to March 30, 2016, at an outpatient, single-center academic setting. Participants included 59 adults with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen with 17-item Hamilton Depression Rating Scale (HDRS-17) scores higher than 17. Data were analyzed in the intention-to-treat sample.

Interventions:

Ten daily 30-minute, 2-mA, anodal-left and cathodal-right prefrontal sessions of active or sham tDCS on weekdays and then 1 session every fortnight until week 6.

Main Outcomes and Measures:

Change in HDRS-17 scores at week 6.

Results:

Fifty-nine patients (40 [68%] women), with a mean (SD) age of 45.9 (12) years participated; 36 (61%) with bipolar I and 23 (39%) with bipolar II disorder were randomized and 52 finished the trial. In the intention-to-treat analysis, patients in the active tDCS condition showed significantly superior improvement compared with those receiving sham (βint = -1.68; number needed to treat, 5.8; 95% CI, 3.3-25.8; P = .01). Cumulative response rates were higher in the active vs sham groups (67.6% vs 30.4%; number needed to treat, 2.69; 95% CI, 1.84-4.99; P = .01), but not remission rates (37.4% vs 19.1%; number needed to treat, 5.46; 95% CI, 3.38-14.2; P = .18). Adverse events, including treatment-emergent affective switches, were similar between groups, except for localized skin redness that was higher in the active group (54% vs 19%; P = .01).

Conclusions and Relevance:

In this trial, tDCS was an effective, safe, and tolerable add-on intervention for this small bipolar depression sample. Further trials should examine tDCS efficacy in a larger sample.

Trial Registration:

clinicaltrials.gov Identifier: NCT02152878.

• Authors: Bernardo Sampaio-Junior, Gabriel Tortella, Lucas Borrione, Adriano H Moffa, Rodrigo Machado-Vieira, Eric Cretaz, Adriano Fernandes da Silva, Renério Fraguas, Luana V Aparício, Izio Klein, Beny Lafer, Stephan Goerigk, Isabela Martins Benseñor, Paulo Andrade Lotufo, Wagner F Gattaz, André Russowsky Brunoni
• Journal: JAMA psychiatry (JAMA Psychiatry) Vol. 75 Issue 2 Pg. 158-166 (02 01 2018) ISSN: 2168-6238 [Electronic] United States
• PMID: 29282470 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Psychotropic Drugs

Topics

• Adult
• Bipolar Disorder (diagnosis, physiopathology, psychology, therapy)
• Combined Modality Therapy
• Depressive Disorder, Major (diagnosis, psychology, therapy)
• Female
• Humans
• Male
• Middle Aged
• Patient Safety
• Prefrontal Cortex (physiopathology)
• Psychotropic Drugs (therapeutic use)
• Transcranial Direct Current Stimulation (methods)
• Treatment Outcome