Home-based brain stimulation for treatment-resistant depression
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment Resistant Depression: a Randomized Clinical Trial
This study is testing whether a home-based brain stimulation treatment can help people with depression who haven't found relief from other therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul) |
| Trial ID | NCT05595356 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of home-based transcranial direct current stimulation (tDCS) in patients suffering from treatment-resistant depression. Participants will undergo a screening process to confirm their diagnosis and will be randomly assigned to receive either active tDCS or a sham treatment. The study aims to measure changes in depressive symptoms using the Hamilton Depression Scale, along with secondary outcomes such as response and remission rates, quality of life, and cognitive function. Data will be collected through participant questionnaires and device downloads to ensure adherence to the treatment protocol.
Who should consider this trial
Good fit: Ideal candidates are outpatients diagnosed with major depressive episodes who have not responded to at least two trials of first-line antidepressants.
Not a fit: Patients with psychotic symptoms, acute risk of hospitalization, or current substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, accessible treatment option for patients with treatment-resistant depression.
How similar studies have performed: Previous studies have shown promise with tDCS for depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Outpatients * Current diagnosis of Major Depressive Episode according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria * Presence of depressive symptoms that did not improve after at least two trials of first line antidepressants, for at least four weeks each, in optimized doses * Patients living in Porto Alegre or its metropolitan region * No changes in prescription in the last four weeks upon entering the trial Exclusion Criteria: * Psychotic symptoms * Acute risk, or indication of hospitalization * Diagnosis of current Substance Use Disorder (alcohol, marijuana, cocaine, sedatives/hypnotics, stimulants, inhalants and others) according to DSM-V criteria * Presence of metallic implants or medical devices implanted in the brain * Pacemakers and cochlear implants * Neurological diseases: epilepsy, malformations * History of head trauma or neurosurgery * Pregnancy * Cognitive impairment severe enough to prevent the operation of the tDCS device without professional assistance
Where this trial is running
Porto Alegre, Rio Grande Do Sul
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcelo Pio de Almeida Fleck, MD — Hospital de Clínicas de Porto Alegre
- Study coordinator: Sofia Azevedo
- Email: projetoetcc@hcpa.edu.br
- Phone: 55 51 99287 6196
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.