High-dose bilateral tDCS for older adults with late-life depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will assess the feasibility, safety, and tolerability of high-dose (6 mA) bilateral tDCS given as three daily sessions, three times a week for three weeks in adults aged 60 and above with late-life depression. The trial uses a phase 1/2 design to explore whether this brain-stimulation approach can be delivered safely and whether participants tolerate the treatment well. Depression severity and adverse events will be monitored to inform future larger studies. Eligible participants must have an MDD diagnosis, stable antidepressant treatment, adequate cognitive status, and an available informant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the following criteria:

1. age 60 years or older;
2. 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);
3. score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
4. stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
5. willingness and capacity to provide informed consent;
6. Clinical Dementia Rating scale of 0 or 0.5.
7. 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:

1. contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
2. contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
3. depressive disorder due to a medical condition;
4. psychotic depression;
5. history of seizures or epilepsy;
6. bipolar disorder;
7. psychotic disorders;
8. severe personality disorder;
9. active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
10. neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
11. active suicidal ideation with plan or intent requiring a higher level of care;
12. concurrent use of medications that substantially lower seizure threshold;
13. pregnancy;
14. a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;
15. medically unstable in the clinical opinion of the principal investigators.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Andre Russowsky Brunoni, MD PhD — University of Texas Southwestern Medical Center
• Study coordinator: Clinical Research Coordinator
• Email: alexus.washington@utsouthwestern.edu
• Phone: 214-645-2991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.