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New treatment option for Depressive Disorder
Official title IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition
ClinicalTrials.gov ID: NCT07197138
What this study is testing
- What it's testing
- 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 (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition (PCC).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- Age \ 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
See the full eligibility 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
- Age \ 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)
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Bavaria, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.