Using transcranial Direct Current Stimulation to treat severe depression in hospitalized patients
A Feasibility Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) in Hospitalized Patients
This study is testing if a new brain stimulation treatment can help hospitalized adults with severe depression who haven't responded to other treatments feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06236711 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of transcranial Direct Current Stimulation (tDCS) as an adjunctive treatment for hospitalized adults with Treatment Resistant Depression (TRD). Over a 5-day period, participants will receive tDCS twice daily, with each session lasting 30 minutes, totaling 10 sessions. Assessments will be conducted before and after treatment to measure changes in depressive symptoms and cognitive function using various standardized scales and EEG data. The study also aims to explore potential biomarkers that may predict response to tDCS.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with a clinical diagnosis of treatment-resistant depression.
Not a fit: Patients with bipolar disorder, active psychotic or substance use disorders, or those with certain neurological conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients suffering from severe depression that has not responded to traditional therapies.
How similar studies have performed: Previous studies have shown promise in using tDCS for depression, but this specific approach in a hospitalized setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 18 years and older * Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks) * Hospitalized in psychiatric units * Voluntary admission status * Moderate or severe depression, defined by PHQ-9 ≥ 15 * Ability to provide informed consent * Ability to adhere to protocol Exclusion Criteria * Bipolar disorder * Active primary psychotic or substance use disorders (except nicotine dependence) within the past year * Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) * Contraindications to tDCS (including pacemaker, metallic implants in the head or neck \[except orthodontic hardware\], skin disease causing irritation) * Current pregnancy or positive urine pregnancy test (clinical) * Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Maria I Lapid, MD — Mayo Clinic
- Study coordinator: Sarah M Williams
- Email: Williams.Sarah2@mayo.edu
- Phone: (507) 422-2972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.