Depressive DisorderIMPACT-D+NCT07197138
IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition
A study testing Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS in people with Depressive Disorder and Post-Acute COVID-19 Syndrome, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial 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 (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Post-Acute COVID-19 Syndrome
- What is being tested?
- Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angelika Erhardt-Lehmann, MD, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
Max-Planck-Institute of Psychiatry
Munich, Bavaria, 80804
Reception Outpatient Clinic, 0049-089-30622-1402, Ambulanz@psych.mpg.de
About this study
Official title: 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 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:
- Standard Arm: One iTBS session per day, five days per week, over six weeks.
- Intensified Arm: Six iTBS sessions per day, approximately one-hour apart, over five consecutive days.
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.
- Conditions
- Depressive Disorder, Post-Acute COVID-19 Syndrome
- Being tested
- Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
- Keywords
- Major depressive disorder, Post-COVID-19-condition, neuropsychology, psychometry, Immunemarkers, IL-6, TNF, CRP, repetitive transcranial magnetic stimulation, intermittent theta burst, accelerated rTMS, neuroinflammation
- Medical subject headings
- Depressive Disorder, Post-Acute COVID-19 Syndrome, Depressive Disorder, Major, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard iTBS (once daily) | Active comparator | 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. Receives: Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS |
| Intensified iTBS (6x daily) | Experimental | 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. Receives: Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start11 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two active iTBS schedules: once-daily for 6 weeks vs six times daily for 5 days; total 30 sessions per participant.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelika Erhardt-Lehmann, MD, Prof., Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197138
- Sponsor's protocol ID
- 25-0648
- Acronym
- IMPACT-D+
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07197138
- Acronym / sponsor ID
- IMPACT-D+ / 25-0648
- Conditions
- Depressive Disorder, Post-Acute COVID-19 Syndrome
- Keywords
- Major depressive disorder, Post-COVID-19-condition, neuropsychology, psychometry, Immunemarkers, IL-6, TNF, CRP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Standard Arm: One iTBS session per day, five days per week, over six weeks.
- Intensified Arm: Six iTBS sessions per day, approximately one-hour apart, over five consecutive days.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two active iTBS schedules: once-daily for 6 weeks vs six times daily for 5 days; total 30 sessions per participant.
| Arm | Type | Receives |
|---|---|---|
| Standard iTBS (once daily) | Active comparator | Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMSStandard: 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. |
| Intensified iTBS (6x daily) | Experimental | Device: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMSIntensified: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMSiTBS 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. | Device | Intensified iTBS (6x daily), Standard iTBS (once daily) |
Primary outcome
Change in immunophenotypic marker CRP from baseline to post-treatment
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) 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)
Change in immunophenotypic marker TNF from baseline to post-treatment
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) 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)
Change in immunophenotypic marker IL-1ß from baseline to post-treatment
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) 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)
Change in immunophenotypic marker IL-6 from baseline to post-treatment
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) 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)
Total score change in the Becks Depression Inventory, version 2 (BDI-II, self-rating)
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 depression symptomatology, comparison between two arms. Range of the test is 0-63, a higher score indicates a worse condition.
Total score change in the clinician-rated Montgomery Asberg Depression scale (MADRS)
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 depression symptomatology, comparison between two arms. Overall score range 0-60, a higher score indicates a more severe depression.
8 secondary outcomes
Change in Fatigue Severity Scale (FSS, self-rating)
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)
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)
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)
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)
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)
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)
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)
Time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment, follow-up 3 months after treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angelika Erhardt-Lehmann, MD, Prof. contact
Angelika Erhardt-Lehmann, MD, Prof. principal investigator
Max-Planck-Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS in people with Depressive Disorder and Post-Acute COVID-19 Syndrome, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Balaskas, MD (0049-089-30622-1402, Ambulanz@psych.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immunophenotypic marker CRP from baseline to post-treatment (time frame: baseline (day of first treatment), day of 15th treatment, 3 days after 30th (last) treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.