← Back to Search

Behavioural Intervention

Transcranial Direct Current Stimulation for Depression (DOS Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

People between the ages of 18 and 85 at the time of screening

Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)

Must not have

Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion)

Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

Summary

This trial aims to test a new method for treating Major Depressive Disorder in cases where traditional treatments have not worked. The method involves using low-intensity electrical currents on the scalp in a more intense and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Transcranial Direct Current Stimulation may cause mild side effects such as itching, tingling, or discomfort at the electrode site, headache, fatigue, nausea or insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old.

Select...

I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have metal implants, seizures, or known brain lesions.

Select...

My depression symptoms haven't worsened by 30% or more recently.

Select...

I need more than 2 mg/day of a benzodiazepine medication.

Select...

I am not using skin treatments like retinoids or alpha hydroxy acids.

Select...

I've had over 15 TMS sessions without noticeable improvement.

Select...

I've had more than 4 ketamine treatments without significant improvement.

Select...

I have a history of undergoing transcranial direct current stimulation.

Select...

I have a history of severe mental health issues, including psychosis or bipolar disorder.

Select...

I have a history of electroconvulsive therapy.

Select...

I have a history of serious neurological conditions or significant head trauma with ongoing symptoms.

Select...

My hormone-related condition is not fully treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline clinical assessment prior to treatment, to 6 weeks after first treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility (Adherence)

Feasibility (Recruitment)

Feasibility (Retention)

+2 more

Secondary study objectives

Biomarker Discovery: Biomarker Discovery: Significant Current Scattering (SCS) via TMS-EEG

Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG)

Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG

+5 more

Trial Design

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.

0 / 13Eligibility criteria met