An interventional study of Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS in Depressive Disorder and Post-Acute COVID-19 Syndrome, sponsored by Max-Planck-Institute of Psychiatry. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Max-Planck-Institute of Psychiatry · Not applicable, Interventional, and Treatment
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). Participants will be randomized into two arms, both receiving a total of 30 active iTBS sessions applied to the left dorsolateral prefrontal cortex (DLPFC) at 90% resting motor threshold using a PowerMAG 100 ppTMS stimulator:
The primary outcomes are changes in immunological blood markers (C-reactive protein [CRP], tumor necrosis factor [TNF], interleukin-1β [IL-1β], interleukin-6 [IL-6]) and depressive symptomatology measured by Beck Depression Inventory-II (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes include fatigue (Fatigue Severity Scale [FSS], Fatigue Scale for Motor and Cognitive Functions [FSMC], Post-Exertional Malaise questionnaire [PEM]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), daytime sleepiness (Epworth Sleepiness Scale [ESS]), functioning (Sheehan Disability Scale [SDS]), anxiety (Beck Anxiety Inventory [BAI]) and an exploratory adverse effect screening. Follow-up assessments will be performed three days after treatment completion and again at three months post-intervention to evaluate both short- and medium-term effects. Biospecimen collection will include approximately 141 ml of peripheral blood per participant across three time points (baseline, post-treatment, +3 days). Samples will be analyzed for inflammatory markers and securely stored in the institutional biobank of the Max Planck Institute of Psychiatry in accordance with data protection and ethical guidelines. Safety and tolerability will be continuously monitored, including documentation of adverse events. The results of this pilot study are expected to provide preliminary evidence on whether accelerated iTBS protocols may exert differential effects on neuroinflammatory processes and depressive symptomatology in patients with Post-COVID-19 condition, thereby informing larger controlled clinical trials.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 42 is below the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Max-Planck-Institute of Psychiatry is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard: Participants receive one iTBS session per day, Monday through Friday, for 6 weeks (total 30 sessions). Each session consists of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (DLPFC) at 90% of resting motor threshold using a PowerMAG 100 ppTMS stimulator. Each session lasts approximately 3 minutes.
Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
Intensified: Participants receive six iTBS sessions per day at intervals of about 60 minutes, for 5 consecutive days (total 30 sessions). Each session uses the same iTBS parameters as in the standard arm: stimulation of the left dorsolateral prefrontal cortex (DLPFC) at 90% of resting motor threshold with a PowerMAG 100 ppTMS stimulator, lasting about 3 minutes per session.
Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
iTBS at 90% resting motor threshold; bursts of 3 pulses at 50 Hz repeated at 5 Hz; \~3 minutes per session; applied to left dorsolateral prefrontal cortex; 30 total sessions; schedule per arm as specified.
Change in immunophenotypic marker CRP from baseline to post-treatment
Differences in CRP from baseline to post-treatment between intensified iTBS and standard iTBS in inflammatory markers (based on material extracted from peripheral blood)
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment
Change in immunophenotypic marker TNF from baseline to post-treatment
Differences in TNF from baseline to post-treatment between intensified iTBS and standard iTBS in inflammatory markers (based on material extracted from peripheral blood)
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment
Change in immunophenotypic marker IL-1ß from baseline to post-treatment
Differences in IL-1ß from baseline to post-treatment between intensified iTBS and standard iTBS in inflammatory markers (based on material extracted from peripheral blood)
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment
Change in immunophenotypic marker IL-6 from baseline to post-treatment
Differences in IL-6 from baseline to post-treatment between intensified iTBS and standard iTBS in inflammatory markers (based on material extracted from peripheral blood)
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment
Total score change in the Becks Depression Inventory, version 2 (BDI-II, self-rating)
Change in depression symptomatology, comparison between two arms. Range of the test is 0-63, a higher score indicates a worse condition.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Total score change in the clinician-rated Montgomery Asberg Depression scale (MADRS)
Change in depression symptomatology, comparison between two arms. Overall score range 0-60, a higher score indicates a more severe depression.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Fatigue Severity Scale (FSS, self-rating)
Change in fatigue severity. Comparison between two arms. Overall score range 9-63, higher scores indicate more severe fatigue.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Fatigue Scale for Motor and Cognitive Functions (FSMC, self-rating)
Change in fatigue across motor and cognitive domains. Comparison between two arms. Overall score range 20-100, higher scores indicate more severe fatigue.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Post-Exertional Malaise (PEM) Questionnaire (self-rating)
Change in post-exertional malaise symptoms, comparison between arms. Exploratory; no standardized range universally defined.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Pittsburgh Sleep Quality Index (PSQI, self-rating)
Change in sleep quality, comparison between arms. Global score range 0-21, higher scores indicate worse sleep quality
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Epworth Sleepiness Scale (ESS, self-rating)
Change in daytime sleepiness, comparison between arms. Total score range 0-24, higher scores indicate greater daytime sleepiness.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Sheehan Disability Scale (SDS, self-rating)
Change in functional impairment across work/school, social, and family life. Each domain scored 0-10; higher scores indicate greater impairment, comparison between arms.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Change in Beck Anxiety Inventory (BAI, self-rating)
Change in self-rated anxiety severity. Total score range 0-63, higher scores indicate more severe anxiety. Comparison between arms.
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Adverse Event Screening (Exploratory)
Incidence of adverse events related to iTBS treatment: headache, scalp discomfort, dizziness, sleepiness, fatigue, and other stimulation-related complaints
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Of 260 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 46. This study's planned 16 months is below that.
Counting every sponsor, half of 274 studies reached it within 29 months; a quarter within 15 and three quarters within 46.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2026 → Jan 2027, on Oct 7, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Max-Planck-Institute of Psychiatry