MDDNCT07422844
Dynamic Network Response to TMS Treatment
An observational study of MDD, run by Goethe University at 1 site in Germany.
Trial summary
This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MDD
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2025to 31 Dec 2031
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Roughly 50 patients will be recruited at the study site in Frankfurt, 25 at the study site in Marburg and 25 at the study site in Gießen. Due to the observational nature of the study, the recruitment process is limited by the TMS treatment capacities of the University Clinics.
Who may be able to join
- Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.
- Men and women will be included in a balanced ratio.
- German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.
Who cannot join
- Patients younger than 18 or older than 70 will be excluded
- Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.
- Further exclusion criteria for participation are acute or chronic neurological diseases.
- Patients who are pregnant will not be included in the study.
- As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Psychiatrie, Psychosomatik und Psychotherapie
Frankfurt am Main, Hesse, 60528
Henry Staub, +4915118991015, staub@med.uni-frankfurt.de
About this study
Official title: Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression
This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment.
Additionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment.
Patients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.
- Conditions
- MDD
- Keywords
- TMS, Brain Networks, Symptom Networks
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Post TMS Treatment Effect Measured by HAMD
Difference Score between pre-TMS and post-TMS on the Hamilton Depression Rating Scale (HAMD).
HAMD: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with 17 and 4 additional items (duration approx. 20 min). For this outcome measure, the first 17 items are used to calculate a sum score for interpretation, because cut-off scores exist for the HAMD-17 version. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 52.
A sum score ≤ 8 indicates no depression. A sum score between 9-16 indicates mild depression. A sum score between 17-24 indicates moderate depression. A sum score ≥ 25 indicates severe depression.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Secondary outcomes (6)
Pre-Post TMS Treatment Effect Measured by MADRS
Difference Score between pre-TMS and post-TMS on the Montgomery-Asberg Depression Rating Scale (MADRS).
MADRS: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with higher sensitivity to change than the HAMD with 10 items (duration approx. 15 min). Higher scores reflect greater symptom intensity. A sum score of the 10 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60.
A sum score ≤ 6 indicates no depression. A sum score between 7-16 indicates mild depression. A sum score between 20-34 indicates moderate depression. A sum score ≥ 35 indicates severe depression.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by IDS-C
Difference Score between pre-TMS and post-TMS on the Inventory of Depressive Symptomatology Clinician Rated (IDS-C).
IDS-C: Standard interview for assessing current depressive symptoms with higher sensitivity to residual symptoms than the HAMD with 30 items. The sum score for interpretation is calculated using 28 of the 30 items. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 84. A sum score ≤ 13 indicates no depression. A sum score between 14-25 indicates mild depression. A sum score between 26-38 indicates moderate depression. A sum score ≥ 48 indicates severe depression.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by HAMA
Difference Score between pre-TMS and post-TMS on the Hamilton Anxiety Rating Scale (HAMA). HAMA: Standard interview to assess the severity of anxiety symptoms (duration approx. 5 min). Higher scores reflect greater symptom severity. A sum score of the 14 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 56. A sum score ≤ 17 indicates mild severity. A sum score between 18-24 indicates mild severity. A sum score between 25-30 indicates moderate to severe. A sum score ≥ 31 indicates severe to very severe.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by YMRS
Difference Score between pre-TMS and post-TMS on the Young Mania Rating Scale (YMRS). YMRS: Standard interview for assessing manic symptoms (duration approx. 10 min). Higher scores reflect greater symptom intensity. A sum score of the 11 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60. A sum score ≤ 12 indicates no or minimal manic symptoms. A sum score between 13-19 indicates mild mania or hypomania. A sum score between 20-25 indicates moderate mania. A sum score ≥ 26 indicates severe mania.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by BDI-II
Difference Score between pre-TMS and post-TMS on the Beck Depression Inventory Version 2 (BDI-II). BDI-II: Standard self-report questionnaire for assessing the severity of current depressive symptoms (duration approx. 4 min). Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 63. A sum score of the 21 items is calculated for interpretation: A sum score ≤ 13 indicates no or minimal depression. A sum score between 14-19 indicates mild depression. A sum score between 20-28 indicates moderate depression. A sum score ≥ 29 indicates severe depression.
Measured: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Patient and Clinician expected treatment outcome
PATHEV questionnaire for patients once before treatment. Expectancy questionnaire for clinician on treatment effect for the patient. Scores on three sub-scales of the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV). PATHEV: Standard questionnaire to evaluate treatment effect expectations (duration approx 3 min). Higher scores on the sub-scales indicate hope of improvement, fear of change and treatment fit. The sub-scales consist of 4, 3 and 4 items. The sum scores range between a minimum of 11 and a maximum of 55.
Measured: pre-TMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start24 Nov 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, Philipps University Marburg
- Responsible party
- Principal investigator, Jonathan Repple, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422844
- Sponsor's protocol ID
- 2025-2352
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression
- ClinicalTrials.gov ID
- NCT07422844
- Acronym / sponsor ID
- 2025-2352
- Conditions
- MDD
- Keywords
- TMS, Brain Networks, Symptom Networks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- University of Giessen, Philipps University Marburg
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Feb 2026 (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 project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment.
Additionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment.
Patients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Roughly 50 patients will be recruited at the study site in Frankfurt, 25 at the study site in Marburg and 25 at the study site in Gießen. Due to the observational nature of the study, the recruitment process is limited by the TMS treatment capacities of the University Clinics.
Key inclusion criteria (3 listed)
- Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.
- Men and women will be included in a balanced ratio.
- German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.
Key exclusion criteria (5 listed)
- Patients younger than 18 or older than 70 will be excluded
- Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.
- Further exclusion criteria for participation are acute or chronic neurological diseases.
- Patients who are pregnant will not be included in the study.
- As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-Post TMS Treatment Effect Measured by HAMD
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Difference Score between pre-TMS and post-TMS on the Hamilton Depression Rating Scale (HAMD). HAMD: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with 17 and 4 additional items (duration approx. 20 min). For this outcome measure, the first 17 items are used to calculate a sum score for interpretation, because cut-off scores exist for the HAMD-17 version. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 52. A sum score ≤ 8 indicates no depression. A sum score between 9-16 indicates mild depression. A sum score between 17-24 indicates moderate depression. A sum score ≥ 25 indicates severe depression.
6 secondary outcomes
Pre-Post TMS Treatment Effect Measured by MADRS
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by IDS-C
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by HAMA
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by YMRS
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Pre-Post TMS Treatment Effect Measured by BDI-II
Time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Patient and Clinician expected treatment outcome
Time frame: pre-TMS treatment
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 20 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDD, run by Goethe University 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 3 inclusion and 5 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 20 Feb 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 Jonathan Repple, Prof. Dr. med. (+4917641633481, repple@uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Post TMS Treatment Effect Measured by HAMD (time frame: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)). 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 20 Feb 2026.