Treatment Resistant Depression (TRD)NCT07834762
Home-Based Randomized Trial of Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression
A study testing Spaced Transcranial Direct Current Stimulation (tDCS) in people with Treatment Resistant Depression (TRD) and Major Depressive Disorder (MDD), run by University of California, San Diego at 1 site in United States.
Trial summary
This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment Resistant Depression (TRD), Major Depressive Disorder (MDD)
- What is being tested?
- Spaced Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 15 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People between the ages of 18 and 70 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 on 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.
- Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.
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- Must be on a stable antidepressant therapeutic regimen for at least 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period. Participants who are not currently on antidepressant treatment are eligible, provided that no discontinuation occurred within the 4 weeks preceding study enrollment.
- 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 childbearing potential: must take a pregnancy test prior to initiating treatment, with results confirmed as negative by study staff
- Participants will need to have a stable internet connection and a device compatible with UCSD Microsoft Teams or UCSD Zoom to facilitate remote communication and engagement in study activities.
Who cannot join
- Pregnancy this includes breastfeeding or trying to becoming pregnant.
- 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.
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
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- 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.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCSD Interventional Psychiatry
San Diego, California, 92127
Edith Jimenez, 858-657-6149, iptrials@health.ucsd.edu
UCSD Interventional Psychiatry Clinic, 858-207-0938
About this study
Official title: Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Randomized Sham-Controlled Trial and Mechanistic Exploration
This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.
- Being tested
- Spaced Transcranial Direct Current Stimulation (tDCS), Sham Spaced tDCS
- Keywords
- tDCS, Treatment Resistant Depression, Major Depressive Disorder, MDD, 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.
Spaced Transcranial Direct Current Stimulation (tDCS)Device
Spaced-tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams).
Sham Spaced tDCSDevice
Soterix Medical mini-CT device sham protocol that match real stimulation parameters will be used.
| Study group | Role | What they receive |
|---|---|---|
| Active spaced-tDCS | Active comparator | Active tDCS applies low-intensity electrical current to the scalp to modulate cortical excitability through subthreshold shifts in neuronal membrane potentials, influencing synaptic plasticity Receives: Device: Spaced Transcranial Direct Current Stimulation (tDCS) |
| Sham spaced-tDCS | Sham comparator | Sham tDCS is a placebo control that simulates the physical sensations of tDCS but does not deliver any actual, prolonged electrical current to the brain. Receives: Device: Sham Spaced tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale
To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.
Measured: Baseline to 4-weeks post treatment
Secondary outcomes (10)
Changes in MADRS with active versus sham spaced tDCS during all post treatment visits
Clinical outcomes associated with active versus sham spaced tDCS as measured by MADRS response (≥50% reduction) and remission (score ≤10) rates.
Measured: 1-week post treatment to 10-week post treatment
Changes in Hamilton Depression Rating Scale, 17-item version scores
Reduction in HAMD-17 scores at all follow-up timepoints. Score range from 0 to 52.
Measured: 1-week post treatment to 10-week post treatment
Changes in Patient Health Questionnaire-9
Changes in PHQ scores at all follow-up timepoints. With scores ranging from 0-27
Measured: 1-week post treatment to 10-week post treatment
Changes in General Anxiety Disorder-7
Changes in GAD-7 scores at all follow-up timepoints. Score range from 0-21
Measured: 1-week post treatment to 10-week post treatment
Changes in The Modified Scale for Suicidal Ideation
Changes in the presence and severity of suicidal thoughts at all follow-up timepoints. Scores ranging from 0-54
Measured: 1-week post treatment to 10-week post treatment
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: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Retention)
Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.
Measured: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Adherence)
The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.
Measured: Baseline clinical assessment to 10 weeks post treatment
Safety of at-home spaced tDCS
Safety will be measured by the number of serious adverse events (SAEs)
Measured: Baseline clinical assessment to 10 weeks post treatment
Tolerability to spaced tDCS
Tolerability will be measured by the number of adverse events (AEs).
Measured: Baseline clinical assessment to 10 weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2031 (estimated)
- Study completion15 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant Depression (TRD)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jean-Philippe Miron, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834762
- Sponsor's protocol ID
- 814732
- Other IDs
- 1K23MH144148-01
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tremblay S, Rogasch NC, Premoli I, Blumberger DM, Casarotto S, Chen R, Di Lazzaro V, Farzan F, Ferrarelli F, Fitzgerald PB, Hui J, Ilmoniemi RJ, Kimiskidis VK, Kugiumtzis D, Lioumis P, Pascual-Leone A, Pellicciari MC, Rajji T, Thut G, Zomorrodi R, Ziemann U, Daskalakis ZJ. Clinical utility and prospective of TMS-EEG. Clin Neurophysiol. 2019 May;130(5):802-844. doi: 10.1016/j.clinph.2019.01.001. Epub 2019 Jan 19.
PubMed 30772238Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8.
PubMed 35839661Borrione L, Cavendish BA, Aparicio LVM, Luethi MS, Goerigk S, Ramos MRF, Moran NKS, Carneiro AM, Valiengo L, Moura DO, de Souza JP, Batista MP, Aparecida da Silva V, Klein I, Suen P, Gallucci-Neto J, Padberg F, Razza LB, Vanderhasselt MA, Lotufo PA, Bensenor IM, Fregni F, Brunoni AR. Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):329-337. doi: 10.1001/jamapsychiatry.2023.4948.
PubMed 38170541Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
PubMed 39433921
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Randomized Sham-Controlled Trial and Mechanistic Exploration
- ClinicalTrials.gov ID
- NCT07834762
- Acronym / sponsor ID
- 814732
- Keywords
- tDCS, Treatment Resistant Depression, Major Depressive Disorder, MDD, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2031 (estimated)
- Study completion
- 15 Oct 2031 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active spaced-tDCS | Active comparator | Device: Spaced Transcranial Direct Current Stimulation (tDCS)Active tDCS applies low-intensity electrical current to the scalp to modulate cortical excitability through subthreshold shifts in neuronal membrane potentials, influencing synaptic plasticity |
| Sham spaced-tDCS | Sham comparator | Device: Sham Spaced tDCSSham tDCS is a placebo control that simulates the physical sensations of tDCS but does not deliver any actual, prolonged electrical current to the brain. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- People between the ages of 18 and 70 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 on 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.
Key exclusion criteria (19 listed)
- Pregnancy this includes breastfeeding or trying to becoming pregnant.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spaced Transcranial Direct Current Stimulation (tDCS)Spaced-tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams). | Device | Active spaced-tDCS |
| Sham Spaced tDCSSoterix Medical mini-CT device sham protocol that match real stimulation parameters will be used. | Device | Sham spaced-tDCS |
Primary outcome
Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale
Time frame: Baseline to 4-weeks post treatment
To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.
10 secondary outcomes
Changes in MADRS with active versus sham spaced tDCS during all post treatment visits
Time frame: 1-week post treatment to 10-week post treatment
Changes in Hamilton Depression Rating Scale, 17-item version scores
Time frame: 1-week post treatment to 10-week post treatment
Changes in Patient Health Questionnaire-9
Time frame: 1-week post treatment to 10-week post treatment
Changes in General Anxiety Disorder-7
Time frame: 1-week post treatment to 10-week post treatment
Changes in The Modified Scale for Suicidal Ideation
Time frame: 1-week post treatment to 10-week post treatment
Feasibility (Recruitment)
Time frame: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Retention)
Time frame: Baseline clinical assessment to 10 weeks post treatment.
Feasibility (Adherence)
Time frame: Baseline clinical assessment to 10 weeks post treatment
Safety of at-home spaced tDCS
Time frame: Baseline clinical assessment to 10 weeks post treatment
Tolerability to spaced tDCS
Time frame: Baseline clinical assessment to 10 weeks post treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 30772238Tremblay S, Rogasch NC, Premoli I, Blumberger DM, Casarotto S, Chen R, Di Lazzaro V, Farzan F, Ferrarelli F, Fitzgerald PB, Hui J, Ilmoniemi RJ, Kimiskidis VK, Kugiumtzis D, Lioumis P, Pascual-Leone A, Pellicciari MC, Rajji T, Thut G, Zomorrodi R, Ziemann U, Daskalakis ZJ. Clinical utility and prospective of TMS-EEG. Clin Neurophysiol. 2019 May;130(5):802-844. doi: 10.1016/j.clinph.2019.01.001. Epub 2019 Jan 19.
- Background: PubMed 35839661Woodham RD, Rimmer RM, Young AH, Fu CHY. Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8.
- Background: PubMed 38170541Borrione L, Cavendish BA, Aparicio LVM, Luethi MS, Goerigk S, Ramos MRF, Moran NKS, Carneiro AM, Valiengo L, Moura DO, de Souza JP, Batista MP, Aparecida da Silva V, Klein I, Suen P, Gallucci-Neto J, Padberg F, Razza LB, Vanderhasselt MA, Lotufo PA, Bensenor IM, Fregni F, Brunoni AR. Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):329-337. doi: 10.1001/jamapsychiatry.2023.4948.
- Background: PubMed 39433921Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spaced Transcranial Direct Current Stimulation (tDCS) in people with Treatment Resistant Depression (TRD) and Major Depressive Disorder (MDD), 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 11 inclusion and 19 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Interventional Psychiatry (858-657-6149, iptrials@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (time frame: Baseline to 4-weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07834762, which also lists 4 linked publications.
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 22 Sep 2026.