Using accelerated brain stimulation to treat difficult depression
Official title: Developing Translational Biomarkers to Predict Clinical Response in Treatment-resistant Depression: Towards a Personalized, Plasticity-enhancing Accelerated Neuromodulation
Run by ITAB - Institute for Advanced Biomedical Technologies · NCT05798143 · Data updated 2026-11-12
This study is testing if a new type of brain stimulation can help people with hard-to-treat depression feel better by looking for signs that show who will benefit the most from the treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | ITAB - Institute for Advanced Biomedical Technologies Academic / other |
| Locations | 1 site (Chieti) |
| Status | Recruiting |
| Started | February 28, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | April 4, 2023 |
| Trial ID | NCT05798143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 who have been diagnosed with treatment-resistant major depressive disorder.
✕Probably not a fit
Patients with co-existing neurological conditions or those who have not responded to previous treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify specific biological markers that predict how well patients with treatment-resistant depression (TRD) will respond to accelerated repetitive transcranial magnetic stimulation (arTMS). The approach involves multiple daily sessions of rTMS, which stimulates targeted brain areas to alleviate depressive symptoms. Participants will undergo psychiatric assessments and cognitive tasks at various points during the treatment to evaluate changes in their condition. The goal is to develop a more effective and personalized treatment protocol for individuals suffering from TRD.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with treatment-resistant depression.
How similar studies have gone: Other studies have shown promise with similar neuromodulation techniques, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Current diagnosis of Major Depressive Disorder (MDD), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5); * Subjects without clinical response to at least two antidepressant treatments administered at adequate dosage and duration during the current episode; * Stable psychopharmacological treatment for at least one month. Exclusion Criteria: * Co-morbidity with organic diseases that could interfere with magnetic stimulation safety (epilepsy, brain lesions or diseases, previous neurosurgery, metal grafts, cardiac devices) based on applied procedure guidelines; * Diagnosis of Substance or Alcohol Use Disorder (DSM-5) in the past 6 months; * Substances of abuse or alcohol acute intoxication or abstinence; * Co-morbidity with significant organic or neurological diseases; * Personal or familiar (1st degree relatives) medical history of seizures; * Significant eye diseases that could interfere with ERG execution; * For female patients: Pregnancy/breastfeeding.
Where it's running
-
Itab
Chieti, Italy Recruiting
Study contacts
- Study coordinator: Mauro Pettorruso, MD, PhD
- Email: mauro.pettorruso@unich.it
- Phone: +393391979487
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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EEG-Guided TMS for Adults With Depression
This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.
-
Ketamine plus behavioral activation therapy for treatment-resistant depression
This study tests whether adding behavioral activation therapy to ketamine treatment helps adults with treatment-resistant depression feel better than ketamine alone.
-
Ketamine-assisted psychotherapy for treatment-resistant depression in adults
This open-label program tests intravenous ketamine combined with psychotherapy to see if it helps adults with treatment-resistant depression.
-
Mindfulness‑augmented brain stimulation for treatment‑resistant depression
This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.
-
ipRGCs as biomarkers to predict TMS response in major depressive disorder
This study tests whether retinal cells called ipRGCs can predict who will respond to TMS in treatment-resistant depression.
-
Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression
This trial tests whether a single-day, robot-guided brain stimulation plus NRX-101 can help adults with treatment-resistant depression compare to sham stimulation and placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.