Using Theta Burst Stimulation for Treatment-Resistant Depression
Efficacy, Clinical and Neuroimaging Biomarkers of Response of Two Intensive/Spaced Protocols of Theta-Burst Transcranial Magnetic Stimulation in Resistant Depression: a Randomized Double-blinded Placebo-controlled Clinical Trial
This study is testing whether a new brain stimulation treatment can help people with depression that hasn't improved with other therapies feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT04998773 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of Theta Burst Transcranial Magnetic Stimulation (TBS) as a treatment for patients with treatment-resistant depression (RTD), including those with bipolar depression. Participants will undergo 22 sessions of either active or sham TBS over six weeks, with assessments of mood changes and neuroimaging conducted before and after treatment. The study aims to develop cost-effective treatment protocols based on clinical and neuroimaging biomarkers to enhance patient adherence and optimize outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with major depressive episodes or depressive phases in bipolar disorder who have not responded to at least two antidepressant treatments.
Not a fit: Patients with psychiatric comorbidities, severe treatment resistance, or contraindications to TMS may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results with TBS in treating depression, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Major Depressive Episode or Depressive phase in Bipolar Disorder DSM-5 criteria. * Moderate severity (\>14 points in HDRS) * 2 antidepressant failures or failure in enhancing strategies in the case of bipolar depression. * No changes in treatment 3 week previous to the onset of treatment with TMS. * Ability to sign informed consent. Exclusion Criteria: * Any psychiatric comorbidity in axis I or II. * Depressive episode with psychotic features. * Dysthymia. * Treatment with ECT in current depressive episode. * Multiresistance (\> 6 trials of therapeutic strategies). * Suicide risk assessed previous to each session. * Patients who miss 2 TMS sessions in a row * Neurological comorbidities (epilepsy, Parkinson disease, neurocognitive disorders). * Contraindications to TMS: pregnancy, metallic cervical or head implants.
Where this trial is running
Valencia
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Pilar Sierra San Miguel, PhD — Instituto de Investigación Sanitaria La Fe
- Study coordinator: Yolanda Cañada, MD
- Email: canyada_yol@gva.es
- Phone: +34961244154
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.