Transcranial Direct Current Stimulation for Depression
(DOS Trial)
Trial Summary
What is the purpose of this trial?
This study aims to evaluate the feasibility, safety, and tolerability of an innovative approach to treating Major Depressive Disorder (MDD), particularly in cases where patients have not responded well to traditional therapies. Specifically, the objective is to evaluate the antidepressant effects of a Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) protocol in participants with treatment-resistant depression (TRD) compared to spaced tDCS only and sham tDCS in a 3-arm randomized controlled trial (RCT). The proposed method involves applying low-intensity electrical currents through the scalp in a manner that is both more intense and more frequently spaced than standard treatments. This approach is hypothesized to lead to a significant reduction in depressive symptoms. Participants in the study will be randomly assigned to one of three groups: the experimental group receiving the DOS-tDCS treatment, a group receiving spaced tDCS only, or a control group receiving a sham (placebo) treatment. Outcomes will be measured over a period of six weeks. The study's goal is to offer a potentially more accessible and effective treatment option for individuals who have not benefited from existing MDD therapies.
Do I have to stop taking my current medications for the trial?
No, you do not have to stop taking your current medications. The trial requires that you stay on a stable antidepressant regimen or not receive treatment for 4 weeks before enrolling and continue this regimen throughout the study.
What data supports the effectiveness of the treatment Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) for depression?
Research suggests that transcranial direct current stimulation (tDCS) can help reduce symptoms of depression, with studies showing it to be more effective than a placebo in improving depression symptoms. However, the effects are moderate, and more research is needed to confirm its effectiveness and determine the best way to use it.12345
Is transcranial direct current stimulation (tDCS) safe for humans?
Transcranial direct current stimulation (tDCS) has been used in over 33,200 sessions with more than 1,000 subjects, including potentially vulnerable populations, without reports of serious adverse effects or irreversible injury. While some skin irritation may occur, the overall safety profile is considered good, with no evidence of serious harm at conventional doses.16789
How is the treatment Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS) different from other treatments for depression?
DOS-tDCS is a non-invasive treatment that uses weak electrical currents applied to the scalp to potentially modify brain function and treat depression. Unlike traditional drug treatments, it is relatively affordable and can be administered at home, but its optimal dosage and long-term effectiveness are still under investigation.1271011
Eligibility Criteria
This trial is for individuals with Major Depressive Disorder (MDD) who haven't had success with traditional treatments. Participants will be involved in a study over six weeks to test an innovative electrical stimulation therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either DOS-tDCS, spaced tDCS, or sham tDCS treatment over a period of six weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dose-Optimized and Spaced Transcranial Direct Current Stimulation
Dose-Optimized and Spaced Transcranial Direct Current Stimulation is already approved in European Union, United States, Canada for the following indications:
- Major Depressive Disorder
- Treatment-Resistant Depression
- Major Depressive Disorder
- Treatment-Resistant Depression
- Major Depressive Disorder
- Treatment-Resistant Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor