Depressive Disorder, Treatment-ResistantPhase 1NCT02942368
Adaptive tDCS for Treatment-Resistant MDD
A Phase 1 study testing tDCS in people with Depressive Disorder, Treatment-Resistant, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2017to 30 Dec 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 to 65
- History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
- Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
- Failure of at least 3 prior lifetime antidepressant trials
- Good command of the English language
Who cannot join
- Lifetime history of the following, defined by DSM-IV criteria per study physician:
- Moderate or severe substance use disorder in the past 6 months with the exception of nicotine use disorder
- Dementia or major neurocognitive disorder
- Schizophrenia spectrum disorders
- Autism spectrum disorder
- Depression which has failed to respond to ECT, with treatment failure as determined by evaluating physician
Show all 26Show fewer
- Failure of greater than 6 antidepressant trials in the current depressive episode
- Current evidence of the following, defined by present symptomology as per study physician:
- Active psychotic symptoms
- Bipolar disorder with a current manic, hypomanic, or mixed episode as defined by DSM-IV criteria
- Depression secondary to a general medical illness
- Dysphoria better explained by a personality disorder
- Dysphoria associated with a primary anxiety disorder or PTSD
- Active suicidal intention (inability to contract for safety)
- Any change in psychotropic medication within 30 days of the initiation of tDCS
- History of neurological disorders (e.g., epilepsy) and/or off any treatment medication for a neurological disorder for minimum 3 years (36 months)
- Any open wounds (e.g., blisters, burns including sun burns, cuts or irritation) under or near the scalp regions where electrodes are placed
- Metal implants (e.g., Deep Brain Stimulator, Vagus Nerve Stimulator)
- Any skin disorders (e.g., eczema, severe rashes, sensitive skin, any communicable skin disorder or treatment for a communicable skin disorder in the past 12 months) or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- Any history of head injury resulting in unconsciousness for more than 5 minutes (e.g., head trauma, brain surgery)
- Metallic face or scalp tattoos
- Any chronic headaches or migraines (occurring for consecutive days and are longer than an hour)
- If a participant has a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they will also be excluded as per study clinician as we are not aiming to assess the treatment of headache with tDCS
- Any personal history of seizures.
- Currently pregnant or lactating, as determined in part from urine pregnancy test at Screening/Baseline appointment and medical history.
- Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
This pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment of major depression in several studies, both as a primary and adjunctive treatment. The treatment will be administered under the supervision of a physician with experience in administering the treatment and monitoring for complications. This will be a prospective "adaptive tDCS stimulation" open label research study. Participants will receive 20 minute sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6 weeks. Building on the theory that greater current "dose" may be a significant factor in determining efficacy, this study aims to determine whether higher tDCS current doses lead to greater improvements in depressive symptoms in this population of patients with treatment-resistant major depressive disorder.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- tDCS
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Anodal placement will be over the left dorsolateral prefrontal cortex region of the head, and cathodal stimulation over the right temporal region, as has been demonstrated in other studies of tDCS for depression. Treatments will take place daily, 5 days per week.
This study will allow tDCS stimulation to be customized for each individual participant and their different threshold for pain. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Measured: Measurements at week 0, week 2, week 4, week 5 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start14 Apr 2017
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: We did not have staff to run this project any longer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a prospective "adaptive tDCS stimulation" single-blind research study (patients and those delivering tDCS will be unblinded, raters will be blinded of design).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Conway, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942368
- Sponsor's protocol ID
- 6610-201610133
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2016
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02942368
- Acronym / sponsor ID
- 6610-201610133
- Conditions
- Depressive Disorder, Treatment-Resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We did not have staff to run this project any longer
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Oct 2016 (estimated)
- 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 pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment of major depression in several studies, both as a primary and adjunctive treatment. The treatment will be administered under the supervision of a physician with experience in administering the treatment and monitoring for complications. This will be a prospective "adaptive tDCS stimulation" open label research study. Participants will receive 20 minute sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6 weeks. Building on the theory that greater current "dose" may be a significant factor in determining efficacy, this study aims to determine whether higher tDCS current doses lead to greater improvements in depressive symptoms in this population of patients with treatment-resistant major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a prospective "adaptive tDCS stimulation" single-blind research study (patients and those delivering tDCS will be unblinded, raters will be blinded of design).
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCSPatients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Anodal placement will be over the left dorsolateral prefrontal cortex region of the head, and cathodal stimulation over the right temporal region, as has been demonstrated in other studies of tDCS for depression. Treatments will take place daily, 5 days per week. This study will allow tDCS stimulation to be customized for each individual participant and their different threshold for pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 18 to 65
- History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
- Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
- Failure of at least 3 prior lifetime antidepressant trials
- Good command of the English language
Key exclusion criteria (26 listed)
- Lifetime history of the following, defined by DSM-IV criteria per study physician:
- Current evidence of the following, defined by present symptomology as per study physician:
- Currently pregnant or lactating, as determined in part from urine pregnancy test at Screening/Baseline appointment and medical history.
- Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region. | Device | tDCS |
Primary outcome
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Time frame: Measurements at week 0, week 2, week 4, week 5 and week 6
Results and safety
The study was stopped early (reason given: We did not have staff to run this project any longer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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. This study is not recruiting at the moment.
Charles Conway, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS in people with Depressive Disorder, Treatment-Resistant, run by Washington University School of Medicine 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 5 inclusion and 26 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: stopped early, as of the sponsor's last update on 9 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We did not have staff to run this project any longer). Results are not available in the source record.
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?
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study. (time frame: Measurements at week 0, week 2, week 4, week 5 and week 6). 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 9 Apr 2026.