tDCS for Late-Life Depression

ConditionsLate Life Depression (LLD)Depression - Major Depressive Disorder

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age60+

SponsorAndre Russowsky Brunoni

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: tDCS in older adults with LLDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Treatment Tolerability

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

Time frame

6 weeks

Treatment Feasibility

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

Time frame

6 weeks

Secondary outcomes

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.

Time frame

6 weeks

Depression Response Rate

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

Time frame

6 weeks

Other outcomes

Target engagement

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.

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andre Russowsky Brunoni

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

Source ClinicalTrials.gov

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