Accelerated intermittent theta-burst stimulation for depression with post‑COVID‑19 condition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.