DepressionDC

The Burkhardt Depression DC trial was a triple blind randomized controlled trial that investigated the efficacy of the TDCS versus Sham stimulation in addition to the stable dose of selective serotonin reuptake inhibitor (SSRI) in adults with Major depressive disorder (MDD).

Major depressive disorder affects about 5% of the total world population. SSRIs are standard first-line treatment in patients with major depressive disorder. However, 30% of the patients did not respond to the SSRI, and 30% did not respond to second-line therapy. So, there is an urgent need for a new treatment to improve patient outcomes.

Study Aim:

The DepressionDC trial was a triple-blind, randomised controlled trial that investigated the efficacy of transcranial direct current stimulation (tDCS) versus sham stimulation as an additional treatment to a stable dose of selective serotonin reuptake inhibitors (SSRIs) in adults with major depressive disorder (MDD).

Primary Endpoint:

The change in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week 6.

Secondary Endpoint:

Clinical response: ≥50% reduction in the Montgomery–Asberg Depression Rating Scale (MADRS) score from baseline to week 6.

Remission:

MADRS score ≤10 at week 6.

Change from baseline to week 6 in the following measures:

Beck Depression Inventory-II (BDI-II)

Clinical Global Impression–Severity (CGI-S) scale

Global Assessment of Functioning (GAF)

Social role functioning and general health subscales of the SF-36

Snaith–Hamilton Pleasure Scale–German version (SHAPS-D)

State and trait anxiety scores on the State-Trait Anxiety Inventory (STAI)

The Burkhardt Depression DC trial was conducted at eight hospitals in Germany. It was a triple blind randomized controlled trial. The participants aged between 18 to 65 years with a diagnosis of major depressive disorder were eligible for this trial if they had a Hamilton Depression Rating Scale (21-item) score ≥15 and a non-response to an antidepressant trial and treatment with a selective serotonin reuptake inhibitor for a minimum of four weeks before study enrolment.

The participants were allocated (1:1) by fixed-block randomization either to receive 30 min of 2mA bifrontal tDCS every weekday for 4 weeks, then two tDCS sessions per week for 2 weeks, or sham stimulation at the same intervals.

Randomization was stratified by site and baseline MADRS score (i.e., <31 or ≥31).