Status:
RECRUITING
IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Conditions:
Depressive Disorder
Post-Acute COVID-19 Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a monocentric, randomized pilot study conducted at the Max Planck Institute of Psychiatry, Munich. The study investigates the effects of two different intermittent theta-burst stimulation (iTB...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07197138
Start Date
September 11 2025
End Date
September 1 2027
Last Update
September 29 2025
Active Locations (1)
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1
Max-Planck-Institute of Psychiatry
Munich, Bavaria, Germany, 80804