Unipolar DepressionNCT07042217
Transcranial Direct Current Stimulation for Depression
A study testing transcranial direct current stimulation (tDCS) and mindfulness instruction in people with Unipolar Depression, run by Soterix Medical at 1 site in United States.
Trial summary
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- transcranial direct current stimulation (tDCS) and mindfulness instruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Dec 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
- Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
- QIDS-SR score >11 on all three days of screening week (Days 1,3, 7)
- Scored at least 17 (inclusive) on the HDRS-17 at trial entry
- Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
- Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
Who cannot join
- Failure to respond to at least 2 antidepressant medications
- Drug or alcohol abuse or dependence in the preceding 3 months
- Concurrent benzodiazepine medication
- High suicide risk assessed during clinician screening at baseline interview.
- Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.
- Current DSM-V-TR psychotic disorder
Show all 11Show fewer
- History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
- Metal in the cranium or skull defects
- Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
- Skin lesions on scalp at the proposed electrode sites
- Pregnancy
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, 1 recruiting
- Recruiting
Soterix Medical, Inc.
Woodbridge, New Jersey, 07095
Paul Thomas, 18889908327, trials@soterixmedical.com
About this study
Official title: A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
- Conditions
- Unipolar Depression
- Being tested
- transcranial direct current stimulation (tDCS) and mindfulness instruction, Sham tDCS and Mindfulness
- Keywords
- tDCS, mindulness, tES, electrotherapy, depression
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS) and mindfulness instructionDevice
tDCS together with audio providing mindfulness instruction and music
Sham tDCS and MindfulnessDevice
Placebo electrical sitmulation and audio-guided mindfulness instruction
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS and Mindfulness | Experimental | Application of electrical stimulation to the brain non-invasively combined with mindfulness Receives: Device: transcranial direct current stimulation (tDCS) and mindfulness instruction |
| Sham tDCS and Mindfulness | Sham comparator | Sham electrical stimulation and mindfulness Receives: Device: Sham tDCS and Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Change in HDRS score from Baseline
Measured: Week 4 and Week 7
Blinding Integrity
Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"
Measured: Week 7
Secondary outcomes (5)
Response and Remission rates defined by HDRS
Response rate, defined as a reduction in the HDRS score by 50% or more, and the remission rate, defined as an HDRS score ≤7.
Measured: Week4, Week 7, Week 10, and Week 13
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)
Safety outcome will be tested using the QIDS-SR through a web portal
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales
Participants will enter responses to the CGI-S and CGI-I questionnaires through the web interface
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Sheehan Disability Scale (SDS)
Participants will be scored on the SDS at Baseline and at the end of the acute and maintenance phases.
Measured: Baseline, Week 7, and Week 13
Montgomery-Asburg Depression Rating Scale (MADRS)
Trained clinical MADRS scores will be obtained at the end of the Acute phase and Maintenance phase.
Measured: Baseline, Week 7 and Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042217
- Sponsor's protocol ID
- ELECTMDS
- Status last verified
- Oct 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07042217
- Acronym / sponsor ID
- ELECTMDS
- Conditions
- Unipolar Depression
- Keywords
- tDCS, mindulness, tES, electrotherapy, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Jun 2025 (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 will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS and Mindfulness | Experimental | Device: transcranial direct current stimulation (tDCS) and mindfulness instructionApplication of electrical stimulation to the brain non-invasively combined with mindfulness |
| Sham tDCS and Mindfulness | Sham comparator | Device: Sham tDCS and MindfulnessSham electrical stimulation and mindfulness |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
- Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
- QIDS-SR score >11 on all three days of screening week (Days 1,3, 7)
- Scored at least 17 (inclusive) on the HDRS-17 at trial entry
- Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
Key exclusion criteria (11 listed)
- Failure to respond to at least 2 antidepressant medications
- Drug or alcohol abuse or dependence in the preceding 3 months
- Concurrent benzodiazepine medication
- High suicide risk assessed during clinician screening at baseline interview.
- Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS) and mindfulness instructiontDCS together with audio providing mindfulness instruction and music | Device | Active tDCS and Mindfulness |
| Sham tDCS and MindfulnessPlacebo electrical sitmulation and audio-guided mindfulness instruction | Device | Sham tDCS and Mindfulness |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: Week 4 and Week 7
Change in HDRS score from Baseline
Blinding Integrity
Time frame: Week 7
Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"
5 secondary outcomes
Response and Remission rates defined by HDRS
Time frame: Week4, Week 7, Week 10, and Week 13
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Sheehan Disability Scale (SDS)
Time frame: Baseline, Week 7, and Week 13
Montgomery-Asburg Depression Rating Scale (MADRS)
Time frame: Baseline, Week 7 and Week 13
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 19 Oct 2026.
- Sponsor's webpage with information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Unipolar Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
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 transcranial direct current stimulation (tDCS) and mindfulness instruction in people with Unipolar Depression, run by Soterix Medical 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Oct 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 Paul Thomas Researcher (18889908327 ext. 104, trials@soterixmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS) (time frame: Week 4 and Week 7). The study lists 2 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 19 Oct 2026.