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Treatment Resistant DepressionDOSNCT06730841

Dose-Optimized and Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression

A study testing Dose-Optimized and Spaced Transcranial Direct Current Stimulation and Spaced Transcranial Direct Current Stimulation in people with Treatment Resistant Depression and Major Depressive Disorder, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Dose-Optimized and Spaced Transcranial Direct Current Stimulation and Spaced Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
26 Sep 2024to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • People between the ages of 18 and 85 at the time of screening.
  • Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
  • 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).
  • Medical records confirming a history of at least moderate treatment-resistance as defined an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
  • MADRS score of ≥20 at screening (Visit 1).
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  • Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.
  • Must be on a stable antidepressant therapeutic regimen, or not receiving treatment for 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period.
  • In good general health, as evidenced by medical history.
  • For persons of child-bearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
  • Agreement to adhere to Lifestyle Considerations (i.e. must continue with any existing treatments) throughout study duration.
  • For persons of child-bearing potential: must take a pregnancy test at the screening visit, with results confirmed as negative by study staff.

Who cannot join

  • An individual will be excluded from participation in this study if they meet any of the following criteria, as determined from a review of medical records prior to screening or at the screening visit:
  • Pregnancy;
  • History of psychotic or bipolar disorder or depression with psychotic features;
  • Significant borderline personality disorder;
  • Significant comorbid obsessive-compulsive or post-traumatic stress disorder;
  • Previously diagnosed Intellectual Disability or Autism Spectrum Disorder;
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  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
  • Clinically significant suicidality;
  • Any history of tDCS;
  • Any history of ECT;
  • History of TMS (greater than 15 sessions) without a clinically meaningful response.
  • History of ketamine (greater than 4 sessions) without a clinically meaningful response;
  • Chronic depression (defined as of over 5 years duration);
  • History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms;
  • Untreated or insufficiently treated endocrine disorder;
  • Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
  • Treatment with an investigational drug or other intervention within the study period;
  • Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score;
  • Require a benzodiazepine with a dose > lorazepam 2 mg/day
  • Has started a new psychotherapeutic process in the past 3 months from screening;
  • Use of potentially irritant topical treatments (ex: retinoids, alpha hydroxy acids)
  • Aesthetic procedure the area of the forehead directly below the stimulation area within the last 6 months (laser, fillers, surgery, etc.)
  • Any active dermatological condition on face or scalp that would in the opinion of the PI represent a contraindication to the treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCSD Interventional Psychiatry

    San Diego, California, 92127

Other trials in United States

About this study

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.

Being tested
Dose-Optimized and Spaced Transcranial Direct Current Stimulation, Spaced Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose-Optimized and Spaced Transcranial Direct Current StimulationDevice

    Also called tDCS, Soterix Medical 1x1 CT

    tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. This group will be treated using a stimulation intensity of up to 4 milliamp (mA).

    Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).

  • Spaced Transcranial Direct Current StimulationDevice

    Also called Soterix Medical 1x1 CT

    tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. Preclinical evidence supports the potential advantage of spaced stimulation with tDCS to maximally engage neuroplasticity. This group will be treated using a stimulation intensity of 2 mA.

    Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).

  • Sham Transcranial Direct Current StimulationDevice

    Also called Soterix Medical 1x1 CT

    tDCS, a non-invasive neuromodulation technique that applies low-intensity, direct electrical stimulation to the cortex via scalp electrodes, has been extensively researched as a potential treatment for MDD. tDCS enhances neuroplasticity, which is theorized to be responsible for its therapeutic effects and has been presented as a cost-effective solution for MDD. This group will be treated using sham stimulation.

    Participants will first complete an acute intensive induction phase consisting of daily treatment every weekday over 2 weeks (10 days total) followed by a consolidation phase consisting of weekly treatments (once a week) over 4 additional weeks (6 weeks total).

Study groups in NCT06730841
Study groupRoleWhat they receive
DOS-tDCS: A dose-optimized and spaced form of tDCSActive comparatorOn 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.
Receives: Device: Dose-Optimized and Spaced Transcranial Direct Current Stimulation
Spaced tDCS: A spaced form of tDCS onlyActive comparatorOn 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.
Receives: Device: Spaced Transcranial Direct Current Stimulation
Sham tDCSSham comparatorOn each treatment day, participants will receive 5 sham tDCS sessions, each lasting 20 minutes, with a 20-minute intersession interval.
Receives: Device: Sham Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility (Recruitment)

    Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

  2. Feasibility (Retention)

    Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

  3. Feasibility (Adherence)

    The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

  4. Safety

    Safety will be measured by the number of serious adverse events (SAEs).

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

  5. Tolerability

    Tolerability will be measured by the number of adverse events (AEs).

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

Secondary outcomes (8)
  1. Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) via TMS-EMG

    TMS-EMG will be used to evaluate changes in SICI.

    Unit of Measurement: Amplitude or percentage inhibition.

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

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

    TMS-EMG will be used to evaluate changes in intracortical facilitation

    Unit of Measurement: Amplitude or percentage facilitation.

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

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

    TMS-EMG will be used to assess changes in the cortical silent period (CSP).

    Unit of Measurement: Duration (milliseconds).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

  4. Biomarker Discovery: TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG

    TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes.

    Unit of Measurement: Voltage (µV).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

  5. Biomarker Discovery: Significant Current Density (SCD) via TMS-EEG

    TMS-EEG will be used to evaluate changes in significant current density (SCD).

    Unit of Measurement: Current density (A/m²).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

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

    TMS-EEG will be used to evaluate changes in significant current scattering (SCS).

    Unit of Measurement: Scattering coefficient (unitless).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

  7. Biomarker Discovery: Resting-State Electroencephalography (rsEEG)

    rsEEG will be used to analyze changes in brain activity patterns at rest.

    Unit of Measurement: Frequency (Hz) and amplitude (µV).

    Measured: From baseline neurophysiological assessment prior to treatment, to during treatment, to 6 weeks after first treatment.

  8. Changes from pre-treatment depressive symptomatology in post-treatment

    Changes in depressive symptoms will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), which ranges from 0 to 60, with higher scores indicating more severe depression. A decrease in the MADRS score will be interpreted as an improvement in symptoms.

    Measured: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start26 Sep 2024
  3. Primary completion1 Aug 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730841
Sponsor's protocol ID
810432
Acronym
DOS
Status last verified
Dec 2024
First submitted
23 Aug 2024
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dose-Optimized and Spaced Transcranial Direct Current Stimulation and Spaced Transcranial Direct Current Stimulation in people with Treatment Resistant Depression and Major Depressive Disorder, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (Recruitment) (time frame: From baseline clinical assessment prior to treatment, to 6 weeks after first treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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