No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Andre Russowsky Brunoni · Other
Who this trial is looking for
This trial is looking for older adults aged 60 and over who are experiencing late-life depression. Participants will receive a treatment involving a non-invasive brain stimulation method delivered three times a week for three weeks.
Are You a Good Fit for This Trial?
Rules you outActive substance use disorderSeizures or epilepsyBipolar disorder
You may be able to join if
I am 60 years old or older.
I have been diagnosed with major depressive disorder.
I have a score of 16 or higher on a depression rating scale.
I have been on a stable antidepressant for at least four weeks, if applicable.
I can give my consent to participate.
I have a Clinical Dementia Rating of 0 or 0.5.
I have someone who knows about my daily functioning.
You may not be able to join if
I have metal implants in my head.
I have skin problems at the stimulation sites.
I have a history of seizures or epilepsy.
I have bipolar disorder.
I have active suicidal thoughts or a plan.
I have a history of substance use disorder in the past six months.
I am currently pregnant.
I am considered medically unstable by the doctors.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-li…
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.
Trial Locations
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Eligibility Criteria
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 D…
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.
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