75 Participants Needed

Transcranial Direct Current Stimulation for Depression

(DOS Trial)

IP
Overseen ByInterventional Psychiatry
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

I have been diagnosed with Major Depressive Disorder.
MADRS score of β‰₯20 at screening (Visit 1)
I have been on a stable antidepressant regimen for 4 weeks or haven't been treated.
See 7 more

Exclusion Criteria

Has started a new psychotherapeutic process in the past 3 months from screening
I don't have metal implants, seizures, or known brain lesions.
I do not have skin conditions on my face or scalp that would interfere with treatment.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DOS-tDCS, spaced tDCS, or sham tDCS treatment over a period of six weeks

6 weeks
5 sessions per day, each lasting 20 minutes, with a 20-minute intersession interval

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Dose-Optimized and Spaced Transcranial Direct Current Stimulation
Trial Overview The study tests a new approach called Dose-Optimized and Spaced Transcranial Direct Current Stimulation (DOS-tDCS), comparing it against standard spaced tDCS and sham treatment in a randomized controlled trial.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: DOS-tDCS: A dose-optimized and spaced form of tDCSActive Control1 Intervention
On each treatment day, participants will receive 5 tDCS sessions, each lasting 20 minutes, with a 20-minute intersession interval. The dose-optimized and spaced tDCS (DOS-tDCS) group will be treated using a stimulation intensity of up to 4 mA.
Group II: Spaced tDCS: A spaced form of tDCS onlyActive Control1 Intervention
On each treatment day, participants will receive 5 tDCS sessions, each lasting 20 minutes, with a 20-minute intersession interval. The spaced tDCS only group will receive stimulation at the standard 2 mA dose.
Group III: Sham tDCSPlacebo Group1 Intervention
On each treatment day, participants will receive 5 sham tDCS sessions, each lasting 20 minutes, with a 20-minute intersession interval.

Dose-Optimized and Spaced Transcranial Direct Current Stimulation is already approved in European Union, United States, Canada for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Transcranial Direct Current Stimulation for:
  • Major Depressive Disorder
  • Treatment-Resistant Depression
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Approved in United States as Transcranial Direct Current Stimulation for:
  • Major Depressive Disorder
  • Treatment-Resistant Depression
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Approved in Canada as Transcranial Direct Current Stimulation for:
  • Major Depressive Disorder
  • Treatment-Resistant Depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Findings from Research

Transcranial direct current stimulation (tDCS) shows potential as a treatment for depression, but current evidence is inconclusive and based on small studies, highlighting the need for larger, controlled trials to assess its safety and efficacy.
Establishing a standardized method for reporting stimulation 'dosage' is crucial for future research, as it will help create evidence-based guidelines for the clinical use of tDCS in treating psychiatric conditions.
Transcranial direct current stimulation for major depression: a general system for quantifying transcranial electrotherapy dosage.Bikson, M., Bulow, P., Stiller, JW., et al.[2021]
A randomized controlled trial (HomeDC) on the use of transcranial direct current stimulation (tDCS) at home for major depressive disorder was prematurely terminated due to safety concerns, specifically skin lesions in patients, highlighting the need for better safety monitoring.
Although the study showed significant reductions in depression scales over time, active tDCS did not demonstrate superior efficacy compared to sham tDCS, indicating that further high-quality research is necessary to explore the potential of tDCS for treating depression.
TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study.Kumpf, U., Palm, U., Eder, J., et al.[2023]
Transcranial direct current stimulation (tDCS) showed significant antidepressant effects in a study of 64 participants with depression, with improved mood after active treatment compared to sham treatment.
While tDCS was generally safe, there was a cautionary note regarding mood switching in individuals with bipolar disorder, as one participant experienced hypomania after treatment.
Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial.Loo, CK., Alonzo, A., Martin, D., et al.[2022]

References

Transcranial direct current stimulation for major depression: a general system for quantifying transcranial electrotherapy dosage. [2021]
TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study. [2023]
Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. [2022]
Notes on Human Trials of Transcranial Direct Current Stimulation between 1960 and 1998. [2022]
Efficacy and acceptability of transcranial direct current stimulation (tDCS) for major depressive disorder: An individual patient data meta-analysis. [2021]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. [2019]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
In-vivo imaging of targeting and modulation of depression-relevant circuitry by transcranial direct current stimulation: a randomized clinical trial. [2021]