Using accelerated brain stimulation to treat difficult depression
Developing Translational Biomarkers to Predict Clinical Response in Treatment-resistant Depression: Towards a Personalized, Plasticity-enhancing Accelerated Neuromodulation
NA · ITAB - Institute for Advanced Biomedical Technologies · NCT05798143
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | ITAB - Institute for Advanced Biomedical Technologies (other) |
| Locations | 1 site (Chieti) |
| Trial ID | NCT05798143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with treatment-resistant major depressive disorder.
Not a fit: Patients with co-existing neurological conditions or those who have not responded to previous treatments may not benefit from this study.
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 performed: Other studies have shown promise with similar neuromodulation techniques, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Chieti
- ITAB — Chieti, Italy (RECRUITING)
Study contacts
- Study coordinator: Mauro Pettorruso, MD, PhD
- Email: mauro.pettorruso@unich.it
- Phone: +393391979487
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.
Conditions: Treatment Resistant Depression, Treatment resistant depression, accelerated repetitive transcranial magnetic stimulation, arTMS, TRD, biomarkers, neuroplasticity