Transcranial Direct Current Stimulation (tDCS) As Treatment for Major Depression – A Prospective Multicenter Double Blind Randomized Placebo Controlled Trial (DepressionDC)
Principal Investigator: Frank Padberg (Munich)
Background and aims
Major depressive disorder (MDD) is a common, frequently recurrent, and often chronic disorder that is a leading contributor to functional impairment and disability. A substantial proportion of patients do not satisfactorily respond to current antidepressant interventions, resulting in a need for additional treatment options. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (BS) method that is has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. PFC tDCS usually targets the dorsolateral PFC (DLPFC) which is interconnected with the medial prefrontal network as well as prefrontal-limbic pathways playing a major role in the pathophysiology of MDD. Theoretically, tDCS constitutes an ideal therapeutic BS approach as it can be easily applied in different health care settings, shows an excellent safety profile in short-term application and superior cost effectiveness compared to other BS methods.
Within this workpackage we investigate the safety and efficacy of prefrontal tDCS on patients with MDD. For this purpose a multicentric randomized, placebo-controlled study will be accomplished with 5 different trial sites (Munich, Berlin, Regensburg, Tübingen, Wasserburg). The aim of the study is the investigation of the safety and efficacy of a 6-weeks treatment with prefrontal tDCS in MDD as adjunctive treatment to a stable antidepressant medication with a selective serotonin reuptake inhibitor (SSRI) which has not led to sufficient clinical improvement. The study will generate safety and efficacy data for an extended tDCS protocol and will also assess the long-term efficacy of tDCS over three to six months. The study is expected to confirm the positive results of a large previous study, but findings will also be important in case of non-confirmation. In addition, this study will generate important safety data for long-term application of tDCS in MDD. The intention is to enroll at least 128 patients diagnosed with MDD who are in a current depressive episode and have not satisfactorily responded to an SSRI. Eligible patients will be randomized to one of two groups. The study group will receive active tDCS treatment and the control group will receive sham treatment both combined with the prior medication with an SSRI.
- Men and women 18-65 years of age
- Primary DSM-5 diagnosis of Major Depression with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks
- Current depressive episode is less than 5 years duration
- Total HDRS-21 ≥15 at the screening visit
- No response to at least one antidepressant treatment of adequate dose and duration in the current episode
- Patient is taking a SSRI of adequate dose and ≥4 weeks in the current episode
- Capable and willing to provide informed consent
- Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential
- Investigators, site personnel directly affiliated with this study, and their immediate families
- Acute risk for suicide
- High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode
- Treatment with electroconvulsive therapy in the present episode
- Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants
- Any other relevant psychiatric axis-I- and/or axis-II-disorder
- Any relevant instable medical condition
- History of treatment with tDCS for any disorder
Is tDCS when combined with antidepressant medication more efficacious as compared to antideperessant medication alone? For this purpose a two-group study design will be applied, comparing the experimental group (active tDCS stimulation) with the control group (sham tDCS stimualtion):
- anodal prefrontal tDCS + antidepressant medication (active group)
- inactive tDCS + antidepressant medication (sham group)
In the treatment period, treatment regimen in both groups will consist of a total of 6 weeks of treatment, consisting of 5 daily treatment sessions per week for 4 weeks and followed by 2 weeks consisting of 2 treatment sessions per week. The study allows for unbiased comparison of active and sham treatment groups.
In order to evaluation the efficacy of the augmentation effect of the tDCS combined with antideperessant medication 3- and 6-month follow-up study visits will be performed.
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