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NCT Number: NCT07657234

tDCS for Late-Life Depression

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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;
  • 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.

Treatment and study plan

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

Primary outcomes

  1. Treatment Tolerability

    Time frame: 6 weeks

    The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.

  2. Treatment Feasibility

    Time frame: 6 weeks

    Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.

Secondary outcomes

  1. Mean change in IDS-C score

    Time frame: 6 weeks

    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.

  2. Depression Response Rate

    Time frame: 6 weeks

    Response is defined as ≥50% reduction in IDS-C from baseline. Proportion of responders at week 6.

Other outcomes

  1. Target engagement

    Time frame: 6 weeks

    Resting-state fMRI measures functional connectivity between the DLPFC and subgenual anterior cingulate cortex (sgACC). The DLPFC-sgACC connectivity is a biomarker of depression that predicts treatment response to neuromodulation.

    Target engagement would be a significant change in DLPFC-sgACC connectivity.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Andre Russowsky Brunoni

Other

Registry information

Official study title

High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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