Abstract
Background: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however ~30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions.Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naïve, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG.Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naïve, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities).Trial Registration: This study is registered with the United States National Library of Medicine Clinical Trials Registry (NCT03548545). Registered June 7, 2018, clinicaltrials.gov/ct2/show/NCT03548545. Protocol Version 1.
Highlights
Major Depressive Disorder (MDD) affects more than 264 million people worldwide
First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes
The current study describes a protocol for a parallel randomized, triple-blind, sham controlled clinical trial to test the synergetic clinical and electrophysiology effects of combining cognitivebehavioral therapy with transcranial direct current stimulation in drug-naïve, first-episode MDD patients
Summary
Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, ∼30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. It is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. MDD is thought to affect 264 million people worldwide, ranking second in the most common causes of disability with prospects of becoming the first by 2040 [3]. 30% of patients suffering from MDD still exhibit depressive symptoms despite the appropriate psychological and pharmacological treatments [5]. The development of effective treatment alternatives for MDD, which includes non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters, is an urgent research priority. In order to do so, it is important to understand the underlying neural mechanisms involved in MDD
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