Accelerated intermittent theta-burst stimulation for depression with post‑COVID‑19 condition
Pilot Study on the Effects of Intensified Repetitive Transcranial Magnetic Stimulation on Immunological Blood Parameters in Patients With Depression and Comorbid Post-COVID-19 Condition
This will test whether two different schedules of intermittent theta-burst stimulation (accelerated TMS) reduce depressive symptoms and inflammation in adults aged 18–65 who have depressive disorder plus post‑COVID‑19 condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Max-Planck-Institute of Psychiatry Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT07197138 on ClinicalTrials.gov |
What this trial studies
This monocentric, randomized pilot at the Max Planck Institute of Psychiatry in Munich compares two iTBS schedules delivered to the left dorsolateral prefrontal cortex: a standard schedule (one session per day over six weeks) and an intensified schedule (six sessions per day over five consecutive days), with both arms receiving 30 active sessions at 90% resting motor threshold using a PowerMAG 100 ppTMS. Participants are adults with at least moderate depression (BDI-II ≥ 20) and a comorbid WHO-defined post‑COVID‑19 condition on stable psychotropic medication. Primary outcomes include changes in circulating immunological markers (CRP, TNF, IL-1β, IL-6) and depressive symptoms measured by the BDI-II and clinician-rated Montgomery–Åsberg scale. The trial is a randomized pilot intended to explore biological and clinical signals rather than provide definitive efficacy results.
Who should consider this trial
Good fit: Adults aged 18–65 with at least moderate depressive disorder (BDI-II ≥ 20), a comorbid post‑COVID‑19 condition per WHO criteria, capacity to consent, and a stable psychopharmacological regimen are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have acute suicidality, psychosis, ongoing substance abuse, severe neurological disorders, current benzodiazepine/Z‑drug treatment, cognitive impairment preventing consent, or are outside the 18–65 age range are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could offer a faster or more effective TMS schedule that improves depressive symptoms and reduces inflammatory markers in people with post‑COVID‑19 condition.
How similar studies have performed: Accelerated iTBS and other accelerated TMS schedules have shown promising antidepressant effects in prior depression studies, but their immune‑modulating effects and specific use in post‑COVID‑19 condition remain largely novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 years * Capacity to consent (legally competent, written informed consent including data protection) * Diagnosis of depression (at least moderate severity, BDI-II ≥ 20), including major depressive episode in bipolar disorder * Comorbid diagnosis of Post-COVID-19 condition (WHO definition) * Insufficient improvement of depressive symptoms under psychopharmacological treatment * Stable psychopharmacological medication for at least 4 weeks prior to start of iTBS Exclusion Criteria: * Age \<18 years or \>65 years * Pregnancy, planned pregnancy, or breastfeeding * Legal guardianship or cognitive impairment preventing valid informed consent * Severe developmental disorder or intellectual disability * Acute or chronic substance abuse (alcohol, prescription drugs, or illicit drugs) * Current treatment with benzodiazepines or Z-substances * Acute suicidality * Psychotic symptoms * Severe neurological disorder (e.g., major brain injury, neurodegenerative disease) * Ongoing treatment with another neurostimulation method (ECT, TMS, VNS) * Contraindications to TMS, including: Intracranial metal, implants, shunts, Cochlear implant, pacemaker, implantable defibrillator, History of seizures or epileptiform EEG * Severe general medical illness (e.g., anemia requiring transfusion, severe arrhythmias, cardiomyopathy)
Where this trial is running
Munich, Bavaria
- Max-Planck-Institute of Psychiatry — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Angelika Erhardt-Lehmann, MD, Prof. — Max-Planck-Institute of Psychiatry
- Study coordinator: Alexandros Balaskas, MD
- Email: Ambulanz@psych.mpg.de
- Phone: 0049-089-30622-1402
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.