Late Life Depression (LLD)Phase 1/2NCT07657234
tDCS for Late-Life Depression
A Phase 1/2 study testing High-intensity (6 mA) transcranial direct current stimulation (tDCS) in people with Late Life Depression (LLD) and Depression - Major Depressive Disorder, run by Andre Russowsky Brunoni at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Late Life Depression (LLD), Depression - Major Depressive Disorder
- What is being tested?
- High-intensity (6 mA) transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- age 60 years or older;
- diagnosis of unipolar major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
- score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
- stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- willingness and capacity to provide informed consent;
- Clinical Dementia Rating scale of 0 or 0.5.
- availability of an informant who has sufficient knowledge of the participant's daily functioning as ascertained by the study team.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
- contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
- depressive disorder due to a medical condition;
- psychotic depression;
- history of seizures or epilepsy;
Show all 16Show fewer
- bipolar disorder;
- psychotic disorders;
- severe personality disorder;
- active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
- neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
- active suicidal ideation with plan or intent requiring a higher level of care;
- concurrent use of medications that substantially lower seizure threshold;
- pregnancy;
- a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;
- medically unstable in the clinical opinion of the principal investigators.
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
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Andre Russowsky Brunoni, MD PhD
About this study
Official title: High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).
The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.
- Being tested
- High-intensity (6 mA) transcranial direct current stimulation (tDCS)
- Keywords
- brain stimulation, tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity (6 mA) transcranial direct current stimulation (tDCS)Device
High-intensity (6 mA), spaced (three daily sessions, 3 times a week, for 3 weeks) transcranial direct current stimulation (tDCS) in older adults (60 y/o and over) with Late-Life Depression
| Study group | Role | What they receive |
|---|---|---|
| tDCS in older adults with LLD | Experimental | Not described Receives: Device: High-intensity (6 mA) transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Tolerability
The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.
Measured: 6 weeks
Treatment Feasibility
Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.
Measured: 6 weeks
Secondary outcomes (2)
Mean change in IDS-C score
Clinical outcomes are assessed using the Inventory of Depressive Symptomatology, Clinician Version (IDS-C) at baseline and week 6.
Mean change in IDS-C score across participants.
Measured: 6 weeks
Depression Response Rate
Response is defined as ≥50% reduction in IDS-C from baseline. Proportion of responders at week 6.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life Depression (LLD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label pilot study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andre Russowsky Brunoni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andre Russowsky Brunoni, University of Texas Southwestern Medical Center
- Investigators
- Andre Russowsky Brunoni, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657234
- Sponsor's protocol ID
- STU20260143
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT07657234
- Acronym / sponsor ID
- STU20260143
- Keywords
- brain stimulation, tDCS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andre Russowsky BrunoniUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Jun 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.
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).
The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label pilot study.
| Arm | Type | Receives |
|---|---|---|
| tDCS in older adults with LLD | Experimental | Device: High-intensity (6 mA) transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 60 years or older;
- diagnosis of unipolar major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
- score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
- stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- willingness and capacity to provide informed consent;
Key exclusion criteria (16 listed)
- contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
- contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
- depressive disorder due to a medical condition;
- psychotic depression;
- history of seizures or epilepsy;
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 |
|---|---|---|
| High-intensity (6 mA) transcranial direct current stimulation (tDCS)High-intensity (6 mA), spaced (three daily sessions, 3 times a week, for 3 weeks) transcranial direct current stimulation (tDCS) in older adults (60 y/o and over) with Late-Life Depression | Device | tDCS in older adults with LLD |
Primary outcome
Treatment Tolerability
Time frame: 6 weeks
The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.
Treatment Feasibility
Time frame: 6 weeks
Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.
2 secondary outcomes
Mean change in IDS-C score
Time frame: 6 weeks
Depression Response Rate
Time frame: 6 weeks
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 25 Sep 2026.
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The Leuven Longitudinal Late-Life Depression Study
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Clinical Risk Score Prediction for Risk of Dementia Among Late-life Population With Depression
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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.
Andre Russowsky Brunoni, MD PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High-intensity (6 mA) transcranial direct current stimulation (tDCS) in people with Late Life Depression (LLD) and Depression - Major Depressive Disorder, run by Andre Russowsky Brunoni 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 8 inclusion and 16 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 25 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Clinical Research Coordinator (214-645-2991, alexus.washington@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Tolerability (time frame: 6 weeks). 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 25 Sep 2026.